Glaucoma treatment device

ABSTRACT

Methods and devices are adapted for implanting into the eye. An incision is formed in the cornea of the eye and a shunt is inserted through the incision into the anterior chamber of the eye. The shunt includes a fluid passageway. The shunt is passed along a pathway from the anterior chamber through the scleral spur of the eye into the suprachoroidal space and positioned in a first position such that a first portion of the fluid passageway communicates with the anterior chamber and a second portion of the fluid passageway communicates with the suprachoroidal space to provide a fluid passageway between the suprachoroidal space and the anterior chamber.

RELATED APPLICATIONS

Benefit of priority under 35 U.S.C. §119(e) is claimed to U.S.Provisional Application Ser. No. 60/759,835, filed Jan. 17, 2006, toEugene de Juan, Jr., Stephen Boyd, Mark E. Deem, Hanson S. Gifford IIIand Angela Macfarlane, entitled “GLAUCOMA TREATMENT DEVICE;” to U.S.Provisional Application Ser. No. 60/783,632, filed Mar. 17, 2006, toEugene de Juan, Jr., Stephen Boyd, Mark E. Deem, Hanson S. Gifford IIIand Angela Macfarlane, entitled “GLAUCOMA TREATMENT DEVICE”; and to U.S.Provisional Application Ser. No. 60/824,396, filed Sep. 1, 2006, toEugene de Juan, Jr., Stephen Boyd, Mark E. Deem, and Hanson S. GiffordIII, entitled “GLAUCOMA TREATMENT DEVICE.”

This application also is related to International PCT application No.PCT/US06/49234 filed the same day herewith.

The subject matter of each of the above-noted provisional applicationsand international applications is incorporated by reference in itsentirety by reference thereto.

BACKGROUND

This disclosure relates generally to methods and devices for use intreating glaucoma. The mechanisms that cause glaucoma are not completelyknown. It is known that glaucoma results in abnormally high pressure inthe eye, which leads to optic nerve damage. Over time, the increasedpressure can cause damage to the optic nerve, which can lead toblindness. Treatment strategies have focused on keeping the intraocularpressure down in order to preserve as much vision as possible over theremainder of the patient's life.

Past treatment has included the use of drugs that lower intraocularpressure through various mechanisms. The glaucoma drug market is anapproximate two billion dollar market. The large market is mostly due tothe fact that there are not any effective surgical alternatives that arelong lasting and complication-free. Unfortunately, drug treatments needmuch improvement, as they can cause adverse side effects and often failto adequately control intraocular pressure. Moreover, patients are oftenlackadaisical in following proper drug treatment regimens, resulting ina lack of compliance and further symptom progression.

With respect to surgical procedures, one way to treat glaucoma is toimplant a drainage device, or shunt, in the eye. The drainage devicefunctions to drain aqueous humour from the anterior chamber and therebyreduce the intraocular pressure. The drainage device is typicallyimplanted using an invasive surgical procedure. Pursuant to one suchprocedure, a flap is surgically formed in the sclera. The flap is foldedback to form a small cavity and a shunt is inserted into the eye throughthe flap. Such a procedure can be quite traumatic as the implants arelarge and can result in various adverse events such as infections andscarring, leading to the need to re-operate.

The following references describe various devices and procedures fortreating glaucoma: U.S. Pat. No. 6,827,700 to Lynch, U.S. Pat. No.6,666,841 to Bergheim, U.S. Pat. No. 6,508,779 to Suson, U.S. Pat. No.6,544,208 to Ethier, U.S. Pat. No. 5,601,094 to Reiss, U.S. Pat. No.6,102,045 to Nordquist, United States Patent Application 2002/0156413 toWilliams, 2002/0143284 to Tu, 2003/0236483 to Ren, 2002/0193725 toOdrich, 2002/0165478 to Gharib, 2002/0133168 to Smedley, 2005/0107734,2004/0260228 to Lynch, 2004/0102729 to Haffner, 2004/0015140 to Shields,2004/0254521 to Simon, and 2004/0225250 to Yablonski. The aforementionedreferences are all incorporated herein by reference in their entireties.

Current devices and procedures for treating glaucoma have disadvantagesand only moderate success rates. The procedures are very traumatic tothe eye and also require highly accurate surgical skills, such as toproperly place the drainage device in a proper location. In addition,the devices that drain fluid from the anterior chamber to asubconjunctival bleb beneath a scleral flap are prone to infection, andcan occlude and cease working. This can require re-operation to removethe device and place another one, or can result in further surgeries. Inview of the foregoing, there is a need for improved devices and methodsfor the treatment of glaucoma.

SUMMARY

Disclosed are devices and methods for treatment of eye disease such asglaucoma. A shunt is placed in the eye wherein the shunt provides afluid pathway for the flow or drainage of aqueous humour from theanterior chamber to the suprachoroidal space. The shunt is implanted inthe eye using a delivery system that uses a minimally invasiveprocedure, as described below. By guiding fluid directly into thesupraciliary or suprachoroidal space rather than to the surface of theeye, complications commonly encountered with conventional glaucomasurgery should be avoided. Shunting aqueous fluid flow directly into thesupraciliary or suprachoroidal space should minimize scarring since theangle region is populated with a single line of non-proliferatingtrabecular cells. Shunting aqueous flow directly into the supraciliaryor suprachoroidal space should minimize hypotony and also potentiallyeliminate complications such as endophthalmitis and leaks since anexternal filtering bleb is not the goal of surgery. The device describedherein is designed to enhance aqueous flow through the normal outflowsystem of the eye with minimal to no complications. Any of theprocedures and device described herein can be performed in conjunctionwith other therapeutic procedures, such as laser iridotomy, laseriridoplasty, and goniosynechialysis (a cyclodialysis procedure).

In one aspect, there is disclosed a glaucoma treatment device comprisingan elongate member having a flow pathway, at least one inflow portcommunicating with the flow pathway, and an outflow port communicatingwith the flow pathway. The inflow port and outflow port are positionedsuch that the flow pathway provides a fluid pathway between an anteriorchamber and a suprachoroidal space when the elongate member is implantedin the eye.

Among the methods provided herein, is a method of implanting an oculardevice into the eye, comprising forming an incision in the cornea of theeye; inserting a shunt through the incision into the anterior chamber ofthe eye wherein the shunt includes a fluid passageway; passing the shuntalong a pathway from the anterior chamber through the scleral spur ofthe eye into the suprachoroidal space; and positioning the shunt in afirst position such that a first portion of the fluid passagewaycommunicates with the anterior chamber and a second portion of the fluidpassageway communicates with the suprachoroidal space to provide a fluidpassageway between the suprachoroidal space and the anterior chamber.

In other embodiments, provided herein is a method of implanting anocular device into the eye, comprising forming an incision in the corneaof the eye; inserting a shunt through the incision into the anteriorchamber of the eye wherein at least a portion of the shunt can be openedto permit fluid flow along the shunt; passing the shunt along a pathwayfrom the anterior chamber through the scleral spur of the eye into thesuprachoroidal space; positioning the shunt in a first position suchthat a first portion of the shunt communicates with the anterior chamberand a second portion of the shunt communicates with the suprachoroidalspace; and opening the shunt to permit fluid flow so that the shuntprovides a fluid passageway between the suprachoroidal space and theanterior chamber.

In other embodiments, provided herein is a method of implanting anocular device into the eye, comprising forming an incision in the corneaof the eye; mounting a shunt on a delivery device wherein at least aportion of the shunt or the delivery device has a curvature that matchesa curvature of the eye; inserting the shunt through the incision intothe anterior chamber of the eye wherein the shunt includes a fluidpassageway; aiming the shunt relative to the suprachoroidal space suchthat the curvature of the shunt or the delivery device aligns with thecurvature of the eye; and inserting at least a portion of the shunt intothe suprachoroidal space to provide a fluid passageway between thesuprachoroidal space and the anterior chamber.

In still further embodiments, provided herein is a method of implantingan ocular device into the eye, comprising forming an incision in thecornea of the eye; inserting a shunt through the incision into theanterior chamber of the eye wherein the shunt includes a fluidpassageway; passing the shunt along a pathway from the anterior chamberthrough the scleral spur of the eye into the suprachoroidal space; andpositioning the shunt in a first position such that a first portion ofthe fluid passageway communicates with the anterior chamber and a secondportion of the fluid passageway communicates with the suprachoroidalspace to provide a fluid passageway between the suprachoroidal space andthe anterior chamber wherein the shunt is pre-shaped to position thefirst portion away from the iris.

In further embodiments, provided herein is a method of implanting anocular device into the eye, comprising forming an incision in the scleraof the eye; inserting a shunt through the incision into thesuprachoroidal space of the eye wherein the shunt includes a fluidpassageway; passing the shunt along a pathway from the suprachoroidalspace through the scleral spur of the eye into the anterior chamber; andpositioning the shunt in a first position such that a first portion ofthe fluid passageway communicates with the anterior chamber and a secondportion of the fluid passageway communicates with the suprachoroidalspace to provide a fluid passageway between the suprachoroidal space andthe anterior chamber.

Also provided herein, is a glaucoma treatment device, comprising anelongate member having a flow pathway, at least one inflow portcommunicating with the flow pathway, and an outflow port communicatingwith the flow pathway, wherein the elongate member is adapted to bepositioned in the eye such that the inflow port communicates with theanterior chamber, the outflow port communicates with the suprachoroidalspace, and at least a portion of the elongate member passes through thescleral spur to provide a fluid pathway between the anterior chamber andthe suprachoroidal space when the elongate member is implanted in theeye.

In other embodiments, provided herein is a glaucoma treatment device,comprising an elongate member having a flow pathway, at least one inflowport communicating with the flow pathway, and an outflow portcommunicating with the flow pathway, wherein the elongate member isadapted to be positioned in the eye such that the inflow portcommunicates with the anterior chamber and the outflow port communicateswith the suprachoroidal space, wherein at least a portion of theelongate member includes an enlarged bulbous region adapted to form aspace within the suprachoroidal space for accumulation of fluid withinthe suprachoroidal space.

In another embodiment, provided herein is a glaucoma treatment device,comprising an elongate member having a flow pathway, at least one inflowport communicating with the flow pathway, and an outflow portcommunicating with the flow pathway, wherein the elongate member isadapted to be positioned in the eye such that the inflow portcommunicates with the anterior chamber and the outflow port communicateswith the suprachoroidal space, the elongate member having a first regionand a second region, wherein the second region is adapted to transitionfrom a first shape to a second shape while the first regions remainsunchanged.

In another embodiment, provided herein is a glaucoma treatment device,comprising a curved member sized to fit within an angle between thecornea and the iris of an eye; at least two legs extending outwardlyfrom the curved member and shaped to extend into the suprachoroidalspace, wherein at least one of the legs provides a fluid flow pathwayinto the suprachoroidal space.

In still further embodiments, provided herein is a glaucoma treatmentsystem, comprising an elongate member having a flow pathway, at leastone inflow port communicating with the flow pathway, and an outflow portcommunicating with the flow pathway, wherein the elongate member isadapted to be positioned in the eye such that the inflow portcommunicates with the anterior chamber and the outflow port communicateswith the suprachoroidal space, wherein at least a portion of theelongate member includes an enlarged bulbous region adapted to form aspace within the suprachoroidal space for accumulation of fluid withinthe suprachoroidal space; and a delivery device having an elongateapplier that removably attaches to the elongate member, the deliverydevice including an actuator that removes the elongate member from theapplier.

Other features and advantages should be apparent from the followingdescription of various embodiments, which illustrate, by way of example,the principles of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-sectional, perspective view of a portion of the eyeshowing the anterior and posterior chambers of the eye.

FIG. 2 is a cross-sectional view of a human eye.

FIG. 3A shows a first embodiment of any eye shunt.

FIG. 3B shows a shunt formed of an elongate wick member through whichfluid can flow.

FIG. 3C shows a shunt that combines a tube and a wicked member.

FIG. 4 shows the shunt including one or more retention structures.

FIG. 5 shows an exemplary embodiment of a delivery system that can beused to deliver the shunt into the eye.

FIG. 6A shows another embodiment of a delivery system.

FIG. 6B shows another embodiment of a delivery system.

FIGS. 6C and 6D show the delivery system of FIG. 6B during actuation.

FIGS. 6E-6G show a distal region of the delivery system during variousstages of actuation.

FIG. 6H shows an enlarged view of an exemplary distal region of anapplier of the delivery system.

FIG. 7 shows an enlarged view of an end region of the shunt.

FIG. 8 shows another embodiment of the shunt wherein a plurality ofholes are located on the side walls of the shunt.

FIG. 9A shows another embodiment of the shunt that includes an elongateportion of fixed size and one or more expansion members.

FIG. 9B shows an embodiment of the expansion members that are formed ofsplayed tines.

FIG. 10 shows another embodiment of the shunt that includes a retainingmember located on the proximal end of the shunt.

FIG. 11 shows an embodiment of the shunt that includes one or moreslots.

FIG. 12 shows an embodiment of the shunt that includes a distal coilmember.

FIG. 13 shows a distal region of an embodiment of the shunt thatincludes a distal coil member and a sharpened distal end.

FIG. 14 shows a cross-sectional view of the eye and a viewing lens.

FIG. 15A shows the delivery system positioned for penetration into theeye.

FIG. 15B shows an embodiment wherein the delivery system is connected toan energy source.

FIG. 16 shows an enlarged view of the anterior region of the eye with aportion of the delivery system positioned in the anterior chamber.

FIG. 17 shows the distal tip of the applier positioned within thesuprachoroidal space.

FIG. 18 shows a shunt having a skirt.

FIG. 19 shows a shunt that is equipped with a pronged skirt.

FIG. 20 shows the skirted shunt positioned in the eye.

FIG. 21 shows a shunt implanted in the eye so as to provide a fluidpathway between the anterior chamber and the suprachoroidal space.

FIGS. 22 and 23 shows shunts that include external fluid flow features.

FIG. 24, 25A, and 25B shows a shunt that includes an elongate outermember mounted over a plug member.

FIG. 26 shows an embodiment of the shunt formed of a sponge-like flowmember.

FIG. 27 shows a shunt as in FIG. 26 having an internal lumen.

FIG. 28 shows an embodiment of the shunt that includes a pair of anchormembers located on opposite ends of the shunt.

FIG. 29 shows an end region of the shunt that includes slices.

FIG. 30 shows an embodiment of the shunt with outer sleeves.

FIG. 31 shows another embodiment of the shunt with sleeves.

FIG. 32 shows another embodiment of the shunt, which has a coiledstructure.

FIGS. 33A and 33B and 34 show embodiments of the shunt that include agrasping loop.

FIG. 35 shows an embodiment of an elongate device with a snare that canbe positioned inside a shunt.

FIG. 36 shows an embodiment of a spatula-shaped end region of a shunt.

FIG. 37 shows a shunt having an atraumatic tip.

FIG. 38 shows an embodiment wherein the shunt that includes a resilientregion.

FIGS. 39, 40A, and 40B show alternate embodiments of the shunt.

FIG. 41 shows an embodiment of the shunt with holes that communicatewith an internal lumen.

FIGS. 42A, 42B, and 43 show embodiments of the shunt that include valvedregions.

FIGS. 44 and 45 show embodiments of the shunt that include one or morebulbous elements.

FIGS. 46 and 47 show embodiments of the bulbous element shunt positionedin the suprachoroidal space.

FIG. 48 shows an embodiment of the shunt that includes a bullet-shapedtip member.

FIG. 49 shows an embodiment of a shunt that mounts over a mandrel.

FIGS. 50 and 51A show embodiments of shunts that change shape afterremoval from a mandrel.

FIG. 51B shows another embodiment of a shunt.

FIG. 51C shows another embodiment of a shunt.

FIG. 52 shows a shunt with a curved proximal region positioned in theeye.

FIG. 53 shows a schematic, front view of the upper region of a patient'sface including the two eyes.

FIGS. 54A and 54B show perspective and plan views of an exemplarydelivery pathway of the applier and shunt during implantation of theshunt into the eye.

FIGS. 55A-55D show plan and perspective views of a delivery system beinginserted into the eye.

FIG. 56 shows a plan view of an exemplary delivery pathway.

FIG. 57 shows a perspective view of an alternate delivery pathway intothe eye.

FIGS. 58A-58D show yet another delivery pathway into the eye.

FIG. 59 shows a shunt having an extension sized and positioned such thata proximal end is positioned over a crest of the iris.

FIG. 60 shows a shunt with a curved extension positioned in the eye.

FIG. 61 shows another embodiment wherein the shunt extends through theiris such that the proximal end and the internal lumen of the shuntcommunicate with the posterior chamber.

FIGS. 62 and 63 show a trans-scleral delivery approach for the shunt.

DETAILED DESCRIPTION

FIG. 1 is a cross-sectional, perspective view of a portion of the eyeshowing the anterior and posterior chambers of the eye. A shunt 105 ispositioned inside the eye such that a proximal end 110 is located in theanterior chamber 115 and a distal end 120 is located in thesuprachoroidal space (sometimes referred to as the perichoroidal space).The shunt 105 is illustrated in FIG. 1 as an elongate element having oneor more internal lumens through which aqueous humour can flow from theanterior chamber 115 into the suprachoroidal space. Embodiments of theshunt 105 with various structural configurations are described in detailbelow.

Exemplary Eye Anatomy

FIG. 2 is a cross-sectional view of a human eye. The eye is generallyspherical and is covered on the outside by the sclera S. The retina Rlines the inside posterior half of the eye. The retina registers thelight and sends signals to the brain via the optic nerve. The bulk ofthe eye is filled and supported by the vitreous body, a clear,jelly-like substance.

The elastic lens L is located near the front of the eye. The lens Lprovides adjustment of focus and is suspended within a capsular bag fromthe ciliary body CB, which contains the muscles that change the focallength of the lens. A volume in front of the lens L is divided into twoby the iris I, which controls the aperture of the lens and the amount oflight striking the retina. The pupil is a hole in the center of the irisI through which light passes. The volume between the iris I and the lensL is the posterior chamber PC. The volume between the iris I and thecornea is the anterior chamber AC. Both chambers are filled with a clearliquid known as aqueous humour.

The ciliary body CB continuously forms aqueous humour in the posteriorchamber PC by secretion from the blood vessels. The aqueous humour flowsaround the lens L and iris I into the anterior chamber and exits the eyethrough the trabecular meshwork, a sieve-like structure situated at thecorner of the iris I and the wall of the eye (the corner is known as theiridocorneal angle). Some of the aqueous humour filters through thetrabecular meshwork into Schlemm's canal, a small channel that drainsinto the ocular veins. A smaller portion rejoins the venous circulationafter passing through the ciliary body and eventually through the sclera(the uveoscleral route).

Glaucoma is a disease wherein the aqueous humor builds up within theeye. In a healthy eye, the ciliary processes secrete aqueous humor,which then passes through the angle between the cornea and the iris.Glaucoma appears to be the result of clogging in the trabecularmeshwork. The clogging can be caused by the exfoliation of cells orother debris. When the aqueous humor does not drain properly from theclogged meshwork, it builds up and causes increased pressure in the eye,particularly on the blood vessels that lead to the optic nerve. The highpressure on the blood vessels can result in death of retinal ganglioncells and eventual blindness.

Closed angle (acute) glaucoma can occur in people who were born with anarrow angle between the iris and the cornea (the anterior chamberangle). This is more common in people who are farsighted (they seeobjects in the distance better than those which are close up). The iriscan slip forward and suddenly close off the exit of aqueous humor, and asudden increase in pressure within the eye follows.

Open angle (chronic) glaucoma is by far the most common type ofglaucoma. In open angle glaucoma, the iris does not block the drainageangle as it does in acute glaucoma. Instead, the fluid outlet channelswithin the wall of the eye gradually narrow with time. The diseaseusually affects both eyes, and over a period of years the consistentlyelevated pressure slowly damages the optic nerve.

Shunt and Delivery System

FIG. 3A shows a first embodiment of the shunt 105. As mentioned, theshunt 105 is an elongate member having a proximal end 110, a distal end120, and a structure that permits fluid (such as aqueous humour) to flowalong the length of the shunt such as through the shunt or around theshunt. In the embodiment of FIG. 3A, the elongate member includes atleast one internal lumen 305 having at least one opening for ingress offluid and at least one opening for egress of fluid. In the embodiment ofFIG. 3A, the shunt includes a single opening in the proximal end 110 anda single opening in the distal end 120 that both communicate with theinternal lumen 305. However, the shunt 105 can include variousarrangements of openings that communicate with the lumen(s), asdescribed below.

The internal lumen 305 serves as a passageway for the flow of aqueoushumour through the shunt 105 directly from the anterior chamber to thesuprachoroidal space. In addition, the internal lumen 305 can be used tomount the shunt 105 onto a delivery system, as described below. Theinternal lumen 305 can also be used as a pathway for flowing irrigationfluid into the eye generally for flushing or to maintain pressure in theanterior chamber, or using the fluid to hydraulically create adissection plane into or within the suprachoroidal space. In theembodiment of FIG. 3A, the shunt 105 has a substantially uniformdiameter along its entire length, although the diameter of the shunt canvary along its length, as described below. Moreover, although the shunt105 is shown as having a circular cross-sectional shape, the shunt canhave various cross-sectional shapes (such as an oval or rectangularshape) and can vary in cross-sectional shape moving along its length.The cross-sectional shape can be selected to facilitate easy insertioninto the eye.

The shunt 105 can include one or more features that aid in properlypositioning the shunt 105 in the eye. For example, the shunt can haveone or more visual, tomographic, echogenic, or radiopaque markers 112that can be used to aid in placement using any of the devices referencedabove tuned to its applicable marker system. In using the markers toproperly place the implant, the shunt is inserted in the suprachoroidalspace, until the marker is aligned with a relevant anatomic structure,for example, visually identifying a marker on the anterior chamberportion of the shunt that aligns with the trabecular meshwork, orscleral spur, such that an appropriate length of the shunt remains inthe anterior chamber. Under ultrasound, an echogenic marker can signalthe placement of the device within the suprachoroidal space. Any markercan be placed anywhere on the device to provide sensory feedback to theuser on real-time placement, confirmation of placement or during patientfollow up. Other structural features are described below.

The shunt 105 can also include structural features that aid in anchoringor retaining the implanted shunt 105 in the eye. For example, as shownin FIG. 4, the shunt 105 can include one or more retaining or retentionstructures 410, such as protrusions, wings, tines, or prongs, that lodgeinto anatomy to retain the shunt in place. The retention structures 410can be deformable or stiff. The retention structures 410 can be made ofvarious biocompatible materials. For example, the retention structures410 can be made from thin 0.001″ thick polyimide, which is flexible,thin 0.003″ silicone elastomer which is also flexible, or stainlesssteel or Nitinol. Alternatively, the retention structures 410 could berings of polyimide. It should be appreciated that other materials can beused to make the retention structures 410. The shape of retentionstructures 410 can vary. For example, FIG. 4 shows the retentionstructures 410 as barb-shaped with pointed edges of the barbs pointingin opposite directions. In other embodiment, the retention structures410 can be rectangular, triangular, round, combinations thereof, orother shapes. Additional embodiments of retention structures 410 aredescribed below.

Other anchoring or retaining features can be employed with the shunt105. For example, one or more hairs, such as human hairs, or synthetichairs made from polymers, elastomers or metals can be attached to theshunt. The hairs cancan be glued or thermally bonded to the shunt. Thehairs, if they are polyimide, can be attached to the shunt by dippingand polymerized by heat and pressure if the dipping material ispolyimide. The hairs can be crimped to the shunt by rings.Alternatively, the shunt can have through-hole features that the hairscan be threaded through and tied or knotted. The hairs can be overmoldedonto the shunt body. The hairs are positioned relative to the shunt suchthat at least a portion of the hair extends outwardly from the shunt foranchoring within or against the tissue of the eye. Various anchoring andretaining features are described herein and it should be appreciatedthat the features can be implemented in any of the shunt embodimentsdescribed herein.

The retaining features, such as wings or collars, can be manufactured byvarious methods. In one embodiment, the retaining features can beinherent in the raw material from which the shunt is constructed. Theshunt can be machined or laser ablated from a unitary rod or block ofstock of material with the material subtracted or removed, leaving theretaining features behind.

Alternatively, the retaining features can be manufactured as separateparts and assembled onto the shunt. They can be joined to the shunt by afriction fit or attached with biocompatible adhesives. They can fit intogrooves, holes or detents in the body of the shunt to lock themtogether. If the retaining features are constructed from hairs orsutures, they can be threaded or tied onto the shunt. Alternatively, theretaining features can be overmolded onto the shunt via an injectionmolding process. Alternatively, the entire shunt and retention featurescan be injection molded in one step. Alternatively, the retainingfeatures can be formed into the shunt with a post-processing step suchas flaring or thermoforming parts of the shunt.

The shunt 105 can be made of various materials, including, for example,polyimide, Nitinol, platinum, stainless steel, molybdenum, or any othersuitable polymer, metal, metal alloy, or ceramic biocompatible materialor combinations thereof. Other materials of manufacture or materialswith which the shunt can be coated or manufactured entirely includeSilicone, PTFE, ePTFE, differential fluoropolymer, FEP, FEP laminatedinto nodes of ePTFE, silver coatings (such as via a CVD process), gold,prolene/polyolefins, polypropylene, poly(methyl methacrylate) (PMMA),acrylic, PolyEthylene Terephthalate (PET), Polyethylene (PE), PLLA, andparylene. The shunt 105 can be reinforced with polymer, Nitinol, orstainless steel braid or coiling or can be a co-extruded or laminatedtube with one or more materials that provide acceptable flexibility andhoop strength for adequate lumen support and drainage through the lumen.The shunt can alternately be manufactured of nylon (polyamide), PEEK,polysulfone, polyamideimides (PAI), polyether block amides (Pebax),polyurethanes, thermoplastic elastomers (Kraton, etc), and liquidcrystal polymers.

Any of the embodiments of the shunt 105 described herein can be coatedon its inner or outer surface with one or more drugs or other materials,wherein the drug or material maintains the patency of the lumen orencourages in-growth of tissue to assist with retention of the shuntwithin the eye or to prevent leakage around the shunt. The drug can alsobe used for disease treatment. The shunt can also be coated on its inneror outer surface with a therapeutic agent, such as a steroid, anantibiotic, an anti-inflammatory agent, an anticoagulant, anantiglaucomatous agent, an anti proliferative, or any combinationthereof. The drug or therapeutic agent can be applied in a number ofways as is known in the art. Also the drug can be embedded in anotherpolymer (nonabsorbable or bioabsorbable) that is coated on the shunt.

The shunt can also be coated or layered with a material that expandsoutward once the shunt has been placed in the eye. The expanded materialfills any voids that are positioned around the shunt. Such materialsinclude, for example, hydrogels, foams, lyophilized collagen, or anymaterial that gels, swells, or otherwise expands upon contact with bodyfluids.

The shunt can also be covered or coated with a material (such aspolyester, ePTFE (also known as GORETEX®), PTFE that provides a surfaceto promote healing of the shunt into the surrounding tissue. In order tomaintain a low profile, well-known sputtering techniques can be employedto coat the shunt. Such a low profile coating would accomplish apossible goal of preventing migration while still allowing easy removalif desired.

In another embodiment shown in FIG. 3B that can be useful in someglaucoma cases depending on how much flow is desired, the shunt 105 isformed of an elongate wick member through which fluid can flow. The wickmember can be formed of a single strand of material or can be formed ofa plurality of strands that are interconnected, such as in a twisted,braided, or woven fashion, and through or along which fluid can flow.The wick member(s) do not necessarily include internal lumens, as flowthrough the wick member can occur via capillary action. In the case of asolid polymer wick, certain surface detents can provide flow lumensbetween the central body member and the tissue of the suprachoroidalspace.

The features of the shunts shown in FIGS. 3A and 3B can be combined asshown in FIG. 3C. Thus, the shunt 105 can include one or more wickmembers 315 in fluid communication with an internal lumen 305 (orexternal lumen) of an elongate member. The flow of aqueous humour occursboth through the internal lumen 305 and through or along the wick member315.

In an exemplary embodiment, the shunt has a length in the range of 0.1″to 0.75″ and an inner diameter for a flow path in the range of 0.002″ to0.015″. In an embodiment, the inner diameter is 0.012″, 0.010″, or0.008″. A wicking shunt can have a diameter in the range of 0.002″ to0.025″. In the event that multiple shunts are used, and for example eachshunt is 0.1″, the fully implanted device can create a length of 0.2″ to1.0″, although the length can be outside this range. An embodiment ofthe shunt is 0.250″ long, 0.012″ in inner diameter, and 0.015″ in outerdiameter. One embodiment of the shunt is 0.300″ long.

The shunt 105 has a column strength sufficient to permit the shunt 105to be inserted into suprachoroidal space such that the distal tip of theshunt 105 tunnels through the eye tissue (such as the ciliary body)without structural collapse or structural degradation of the shunt 105.In addition, the surface of the inner lumen 305 is sufficiently smoothrelative to the delivery device (described in detail below) to permitthe shunt 105 to slide off of the delivery device during the deliveryprocess. In an embodiment, the column strength is sufficient to permitthe shunt to tunnel through the eye tissue into the suprachoroidal spacewithout any structural support from an additional structure such as adelivery device.

The shunt 105 can be configured to transition between a first state ofreduced size and a second state of expanded size. For example, the shunt105 can be in a first state wherein the shunt 105 has a reduced radialsize and/or overall length in order to facilitate fitting the shuntthrough a small portal during delivery. The shunt can then transition toa second state of increased radial size and/or overall length. The shuntcan also change cross sectional shape along the length.

The transition between the first and second states can be implemented invarious manners. For example, the shunt can be manufactured of amaterial such as Nitinol that deforms in response to temperaturevariations or a release of a constraining element. Thus, the shunt canbe self-expanding or self-restricting at various locations along thelength. In another embodiment or in combination with a self-expandingshunt, the shunt can be expanded manually, such as through use of anexpansion balloon or by passing the shunt along a pre-shaped device,such as a reverse-tapered delivery trocar that increases in diameter. Inaddition, the shunt can be positioned inside a sheath during deliverywherein the sheath maintains the shunt in the first state of reducedsize. Upon delivery, the sheath can be removed to permit the shunt toexpand in size.

FIG. 5 shows an exemplary delivery system 510 that can be used todeliver the shunt 105 into the eye pursuant to methods described indetail below. The delivery system 510 includes a handle component 515that controls a shunt placement mechanism, and a delivery component 520that removably couples to the shunt 105 for delivery of the shunt 105into the eye. The delivery component 520 includes an elongate applier525. In one embodiment, the applier 525 has a sharpened distal tip. Theapplier 525 is sized to fit through the lumen in the shunt 105 such thatthe shunt 105 can be mounted on the applier 525. The applier 525 canhave a cross-sectional shape that complements the cross-sectional shapeof the internal lumen of the shunt 105 to facilitate mounting of theshunt onto the applier 525. It should be appreciated the applier 525does not have to employ a sharpened distal tip. The applier 525 can havean atraumatic or blunt distal tip such that it serves as a component forcoupling to the shunt, or performing blunt dissection, rather than as acutting component.

The delivery component 520 also includes a shunt deployment or advancingstructure 530 positioned on a proximal end of the applier 525. Theadvancing structure 530 can be an elongated tube that is positioned overthe applier 525. The delivery system 510 can be actuated to achieverelative, sliding movement between the advancing structure 530 and theapplier 525. For example, the advancing structure 520 can be moved inthe distal direction (as represented by the arrow 532), while theapplier 525 remains stationary to push or otherwise advance the shunt105 along the applier 525 for delivery of the shunt 105 into the eye. Inan alternate embodiment, the applier 525 withdraws distally into theadvancing structure 530 to remove the shunt 105 from the applier 525, asdescribed below with reference to FIG. 6B. In yet another embodiment,both the advancing structure 530 and the applier 525 move relative toone another to remove the shunt 105.

In an embodiment, the applier 525 can have a length sufficient toreceive a plurality of shunts in an end-to-end series arrangement on theapplier 525. In this manner, multiple shunts 105 can be loaded onto theapplier 525 and delivered one at a time such that the shuntscollectively form an elongated lumen of sufficient length for adequatedrainage. This permits relatively short length shunts that can becollectively used in various eye sizes. In addition, multiple shunts canbe placed in multiple separate locations within one eye.

The applier 525 or any portion of the delivery component 520 can have aninternal lumen that extends along its length for receipt of a guidewirethat can be used during delivery of the shunt 105. The internal lumen inthe delivery component 520 can also be used for the flow of fluid inorder to irrigate the eye. The internal lumen can be sufficiently largeto receive the shunt 105 such that the shunt 105 is mounted inside theapplier 525, rather than over the applier 525, during delivery.

The handle component 515 of the delivery system 510 can be actuated tocontrol delivery of the shunt 105. In this regard, the handle component515 includes an applier control 540 that can be actuated to cause theapplier 525 to extend in length in the distal direction or to retract inthe opposite direction (proximal direction). The handle component 515also includes an implant advancing actuator 535 that can be actuated toselectively move the advancing structure 530 along the applier 525 inthe proximal or distal direction. In this manner, the advancingstructure 530 can be used to push the shunt 105 in the distal directionand off of the applier 525 during delivery, or else to hold the shunt105 in a fixed location in the eye while the applier 525 is withdrawn.

The handle component 515 can be adapted such that it can be actuatedusing only a single hand. In addition, the delivery system 510 caninclude an actuation member that is separate from the handle 515 suchthat the operator can use a foot to actuate the delivery system 510. Forexample, a foot pedal or hydraulics can be coupled to or incorporatedwithin the delivery system 510 to save the use of the physician's handat the worksite. Thus, the physician simply positions a cannula ordelivery system with his or her hands and uses the foot pedal to advancethe shunt. PCT Publication No. WO06012421, which is incorporated hereinby reference in its entirety, describes an exemplary hydraulic assistfor an ablation catheter with a steerable tip.

In another embodiment, some of the functions of the applier 525 and theshunt 105 are combined. That is, the distal tip of the shunt 105 canhave a pointed or other type of shape (such as a beveled or bluntedshape) on the distal end that facilitates penetration of the shunt 105through tissue. Exemplary methods for delivering the shunt 105 into theeye are described in detail below.

As mentioned, the applier 525 can be equipped with one or moremechanisms that cause expansion of the shunt 105. For example, theapplier 525 can include an expandable structure, such as an inflatablesheath, that is mounted over a solid core of the applier 525. Theinflatable sheath is positioned at least partially within the internallumen of the shunt 105 when the shunt 105 is mounted on the applier 525.During delivery of the shunt 105, the inflatable sheath is expanded whenthe shunt 105 is positioned in the appropriate location in the eye toexpand the shunt 105 and cause the shunt 105 to lodge in the location.The sheath is then deflated or otherwise reduced in size to permit theapplier 525 to be withdrawn from the shunt 105. Exemplary methods aredescribed below.

The applier 525 can be made of various materials, including, forexample, stainless steel and Nitinol. The applier 525 can be straight(as shown in FIG. 5) or the applier 525 can be curved along all or aportion of its length (as shown in FIG. 6A) in order to facilitateproper placement through the cornea. In this regard, the curvature ofthe applier 525 can vary. For example, the applier 525 can have a radiusof curvature of 3 mm to 50 mm and the curve can cover from 0 degrees to180 degrees. In one embodiment, the applier 525 has a radius ofcurvature that corresponds to or complements the radius of curvature ofa region of the eye, such as the suprachoroidal space. For example, theradius of curvature can be around 12 mm. Moreover, the radius ofcurvature can vary moving along the length of the applier 525. There canalso be means to vary the radius of curvature of portions of the applier525 during placement.

The applier can also have a structure that enables or facilitates use ofthe applier 525. For example, the distal tip of the applier 525 can havea shape that facilitates blunt dissection of targeted tissue such as tofacilitate dissection into the suprachoroidal space. In this regard, thedistal tip of the applier 525 can have a flat, shovel, spade, etc.shape, for example.

FIG. 6B shows another embodiment of the delivery device 510. The handlecomponent 515 includes an actuator comprised of a knob 550 that canslide relative to the handle component 515. The knob 550 serves as anactuator that controls relative, sliding movement between the advancingmember 530 and the applier 525. For example, with reference to FIGS. 6Cand 6D, the advancing member 530 can be fixed relative to the handlecomponent 515. In a first state shown in FIG. 6C, the applier 525 isextended outwardly relative to the advancing member 530. Movement of theknob 550, such as in the proximal direction, causes the applier 525 toslide proximally into the advancing element 530 as shown in FIG. 6D.

This is described in more detail with reference to FIG. 6E, which showsthe shunt 105 mounted on the applier 525 distal of the advancingstructure 530. When the knob 550 is actuated, the applier 525 slides inthe proximal direction and into the advancing structure 530, as shown inFIG. 6F. The proximal edge of the shunt 105 abuts the distal edge of theadvancing structure 530 to prevent the shunt 105 from sliding in theproximal direction. Thus, the applier 525 gradually withdraws from theshunt 105. As shown in FIG. 6G, the applier 525 can be fully withdrawninto the advancing structure 530 such that the shunt 105 is releasedfrom the applier 525.

FIG. 6H shows an enlarged view of an exemplary distal region 537 of theapplier 525. The distal region 537 of the applier 525 can be shaped tofacilitate an approach into the suprachoroidal space. In this regard, asmentioned above, the distal region 537 can have a curved contour thatcompliments the curved contour of the dissection plane, such as thesuprachoroidal space.

At least a portion of the applier 525 can be flexible. For example, thedistal region 537 of the applier 525 can be flexible such that itconforms to the shape of the shunt 105 when the shunt 105 is mounted onthe distal region 537. The distal region 537 can also conform to theshape of the advancing element 530 when the applier 525 is withdrawninto the advancing element 530.

Various other embodiments of the shunt 105 are now described. Thereference numeral 105 is used to refer to all embodiments of the shuntand it should be appreciated that features in the various embodimentscan be combined with other embodiments. As mentioned, the shunt 105 caninclude various types of structures and mechanisms for retaining orotherwise anchoring the position of the shunt 105 in the eye. Forexample, the shunt 105 can be equipped with a structure (such as a meshstructure or spray coating) that facilitates endothelial growth oftissue around the shunt for permanent placement of the shunt.

FIG. 7 shows an enlarged view of an end region, such as the distal endregion, of the shunt 105. The end region includes retaining structurescomprised of one or more fenestrations, slits or slots 705 located onthe shunt 105. The slots 705 are shown arranged in a series along theend region of the shunt 105, although it should be appreciated that thespatial configuration, size, and angle of the slots 705 can vary. Theshunt 105 shown in FIG. 7 has a distal wall 710 that at least partiallyencloses the distal end of the internal lumen. The distal wall 710 canhave a slot 705 for fluid flow into and out of the lumen. Alternately,the distal wall 710 can be absent such that an opening is present forthe flow of fluid. The slots can operate to allow fluid flow in additionto the central lumen of the shunt 105.

The slots 705 form edges that interface with surrounding tissue toprevent the shunt 105 from becoming dislodged once implanted in the eye.The slots 705 form holes that communicate with the internal lumen of theshunt 105 for inflow and outflow of aqueous humour relative to thelumen. The proximal end of the shunt can also be equipped with anarrangement of slots 705.

FIG. 8 shows another embodiment of the shunt 105 wherein a plurality ofholes are located on the side walls of the shunt 105 and interspersedalong the length of the shunt 105. The holes facilitate the flow offluid into and out of the internal lumen of the shunt 105. The shunt 105can be configured such that it initially does not have any holes. Afterthe shunt 105 is placed in the eye, one or more holes can be formed inthe shunt, such as by applying a laser (e.g., a YAG laser) to the shunt105 or using other means to form the holes.

Each of the holes can communicate with a separate flow path that extendsthrough the shunt 105. That is, the shunt 105 can include a plurality ofinternal lumens wherein each internal lumen communicates with one ormore of the holes in side wall of the shunt.

FIG. 9A shows another embodiment of the shunt 105 that includes anelongate portion 905 of fixed size and one or more expansion members910. The elongate portion 905 includes an internal lumen and one or moreopenings for ingress and egress of fluid relative to the lumen. Theexpansion members 910 are configured to transition between a first stateof reduced size and a second state of expanded or increased size. Thestructure of the expansion members 910 can vary. In the illustratedembodiment, each expansion member 910 is formed of a plurality ofaxially-extending rods or tines that are connected at opposed ends. Therods can deform outward along their length to expand the radial size ofthe expansion member 910. The expansion of the expansion members 910 canbe implemented in various manners, such as by using an expansion balloonor by manufacturing the expansion members of a material such as Nitinolthat deforms or expands in response to temperature variations or aretractable sheath 915 that allows expansion of a shunt formed from aresilient material. The expansion members can also be biased outwardsuch that they self-expand when unrestrained.

As shown in FIG. 9B, an embodiment of the expansion members 910 areformed of tines that are splayed or fanned outward. The tines areconfigured to hold tissue of the suprachoroidal space open. Either oneor both of the expansion members 910 can include splayed tines. Forexample, the expansion member 910 a can be as configured in FIG. 9A,while the expansion member 910 b can be as configured in FIG. 9B (orvice-versa). Furthermore, the shunt can include three or more expansionmembers.

The expansion members 910 can be biased toward the expanded state suchthat, when unopposed, the expansion members 910 automatically movetoward the expanded state. In such a case, each of the expansion members910 can be positioned within a sheath 915 during delivery, wherein thesheath 915 maintains the expansion members 910 in the reduced-sizestate. The sheath 915 is removed from the expansion members to permitthe expansion members 910 to self-expand. The sheath 915 can have astrong hoop and tensile strength to hold the expansion members 910 in anunexpanded state until the shunt 105 in a proper place in the eye. Inone embodiment, the sheath 915 is manufactured of PolyEthyleneTerephthalate (PET).

The embodiment of FIG. 9A includes a first expansion member 910 a on adistal end of the shunt 105 and a second expansion member 910 b on aproximal end of the shunt 105. It should be appreciated that thequantity and location of the expansion members 910 on the shunt canvary. For example, the shunt 105 can include only a single expansionmember 910 on either the proximal end or the distal end, or couldinclude one or more expansion members interspersed along the length ofthe portion 905. Expansion members can be configured in other geometriese.g. latticed, coiled or combinations of each.

FIG. 10 shows another embodiment of the shunt 105 that includes aretaining member 1005 located on the proximal end of the shunt 105. Theretaining member 1005 has an enlarged size with respect to the remainderof the shunt and has a shape that is configured to prevent the shuntfrom moving further into the suprachoroidal space after being properlypositioned. The enlarged shape of the retaining member 1005 can lodgeagainst tissue to prevent movement of the shunt 105 into or out of apredetermined location, such as the suprachoroidal space. The retainingmember 1005 of FIG. 10 has a funnel or cone-like shape, although theretaining member 1005 can have various shapes and sizes that areconfigured to prevent the shunt from moving further into thesuprachoroidal space. For example, the retaining member 1005 can have aplate or flange-like shape.

The shunt 105 of FIG. 10 is tapered moving along its length such thatthe diameter of the shunt 105 gradually reduces moving in the distaldirection. The distal direction is represented by the arrow 532 in FIG.10. The tapered configuration can facilitate a smooth insertion into theeye. The taper can exist along the entire length of the shunt or it canexist only along one or more regions, such as a distal region. Further,the shunt can have a bulbous section at approximately its midpoint tocreate an additional means to anchor. The bulbous section can be anexpandable member or balloon element. Shunts with bulbous sections aredescribed in detail below.

As mentioned, the shunt 105 includes an internal lumen. The lumen canhave a uniform diameter along the length of the shunt or that can varyin diameter along the length of the shunt. In this regard, the diameterof the internal lumen can taper in a manner that achieves a desiredfluid flow rate through the shunt. Thus, the diameter of the lumen canbe varied to regulate fluid flow through the shunt. Flow regulation canalso be achieved by variation in size, quantity, and/or position ofholes 1010 in the distal region of the shunt 105, wherein the holes 1010communicate with the internal lumen. Thus, the holes 1010 can haveshapes, sizes, and quantities that are selected to achieve a desiredintraocular pressure of the eye as a result of the flow of aqueoushumour through the shunt. In addition, the use of multiple holes permitfluid to flow through the shunt 105 even when one of the holes 1010 isblocked.

During delivery of the shunt 105, the holes 1010 can be positioned so asto align with predetermined anatomical structures of the eye. Forexample, one or more holes 1010 can align with the suprachoroidal spaceto permit the flow of aqueous humour into the suprachoroidal space,while another set of holes 1010 aligns with structures proximal to thesuprachoroidal space, such as structures in the ciliary body or theanterior chamber of the eye. The shunt can have visual markers along itslength to assist the user in positioning the desired portion of theshunt within the anterior chamber. Further, the shunt and deliverysystem can employ alignment marks, tabs, slots or other features thatallow the user to know alignment of the shunt with respect to thedelivery device.

FIG. 11 shows an embodiment of the shunt 105 that includes one or moreslots 1105 that are positioned around the circumference of the shunt.The slots 1105 provide variations in the shunt structure that permit theshunt to flex during delivery such as to enable proper placement of theshunt 105 from the anterior chamber of the eye to the suprachoroidalspace. The shunt 105 can also be manufactured of a flexible materialwith or without slots 1105. The shunt 105 can have other features thatprovide flexibility to the shunt. For example, the shunt can be scoredor laser cut for flexibility at various locations along the shunt. Thescores can be located at various positions along the length of the shunt105 to provide localized variation in the flexibility of the shunt. Forexample, a distal region can have a plurality of scores to provideincreased flexibility, while a proximal region includes a reduced numberof scores that provide less flexibility than the distal region.

FIG. 12 shows an embodiment of the shunt 105 that includes a distal coilmember 1205. The coiled configuration of the coil member 1205 providesincreased flexibility to the distal region of the shunt 105 tofacilitate traction into the suprachoroidal space. Moreover, the coilmember 1205 can facilitate fluid flow from the internal lumen into thesuprachoroidal space. The coil member 1205 can permit a screwing motionto advance and/or secure the shunt 105 in the eye. The distal tip of theshunt 105 can have an atraumatic shape, such as a ball shape (as shownin FIG. 12). The distal tip can alternately have a sharpened tip and ashape with barbs that retains the shunt in the eye, as shown in FIG. 13.Any of the features that are described herein as being on the distal tipcould also be located on the proximal tip of the shunt.

Exemplary Methods of Delivery and Implantation

An exemplary method of delivering and implanting the shunt into the eyeis now described. In general, the shunt is implanted using the deliverysystem by accessing the scleral spur to create a low profile dissectionin the tissue plane between the choroid and the sclera. The shunt isthen secured in the eye so that it provides communication between theanterior chamber and the suprachoroidal space.

FIG. 14 shows a cross-sectional view of the eye. A viewing lens 1405(such as a gonioscopy lens represented schematically in FIG. 14) ispositioned adjacent the cornea. The viewing lens 1405 enables viewing ofinternal regions of the eye, such as the scleral spur and scleraljunction, from a location in front of the eye. The viewing lens 1405 canoptionally include one or more guide channels 1410 that are sized toreceive the delivery portion 520 of the delivery device 510. It shouldbe appreciated that the locations and orientations of the guide channels1410 in FIG. 14 are merely exemplary and that the actual locations andorientations can vary depending on the angle and location where theshunt 105 is to be delivered. An operator can use the viewing lens 1405during delivery of the shunt into the eye. The viewing lens 1405 canhave a shape or cutout that permits the surgeon to use the viewing lens1405 in a manner that does not cover or impede access to the cornealincision. Further, the viewing lens can act as a guide through which adelivery device 510 can be placed to predetermine the path of the deviceas it is inserted through the cornea.

An endoscope can also be used during delivery to aid in visualization.For example, a twenty-one to twenty-five gauge endoscope can be coupledto the shunt during delivery such as by mounting the endoscope along theside of the shunt or by mounting the endoscope coaxially within theshunt. Ultrasonic guidance can be used as well using high resolutionbio-microscopy, OCT and the like. Alternatively, a small endoscope canbe inserted though another limbal incision in the eye to image thetissue during the procedure.

In an initial step, one or more shunts 105 are mounted on the deliverydevice 510 for delivery into the eye. As mentioned, at least one shunt105 can be mounted over the applier 525 or can be mounted within theapplier 525. The eye can be viewed through the viewing lens 1405 orother viewing means such as is described above, in order to ascertainthe location where the shunt 105 is to be delivered. At least one goalis to deliver the shunt 105 in the eye so that it is positioned suchthat the internal lumen of the shunt provides a fluid pathway betweenthe anterior chamber and the suprachoroidal space. If a tube shunthaving an internal lumen is used, then the internal lumen is positionedsuch that at least one ingress to the lumen communicates with theanterior chamber and at least one egress communicates with thesuprachoroidal space. If a wick shunt is used, then the wick member cancommunicate with both the anterior chamber and the suprachoroidal space.As mentioned, the tube member and wick member can be combined. In such acase, the internal lumen can be open into the anterior chamber and beopen at least partially into the suprachoroidal space, while the wickmember extends further into the suprachoroidal space.

With reference to FIG. 15A, the delivery device 510 is positioned suchthat the distal tip of the applier 525 or the shunt 105 itself canpenetrate through the cornea. In this regard, an incision is madethrough the eye, such as within the limbus of the cornea. In anembodiment, the incision is very close to the limbus, such as either atthe level of the limbus or within 2 mm of the limbus in the clearcornea. The applier 525 can be used to make the incision or a separatecutting device can be used. For example, a knife-tipped device ordiamond knife can be used to initially enter the cornea. A second devicewith a spatula tip can then be advanced over the knife tip wherein theplane of the spatula is positioned to coincide with the dissectionplane. Thus, the spatula-shaped tip can be inserted into thesuprachoroidal space with minimal trauma to the eye tissue.

The incision has a size that is sufficient to permit passage of theshunt therethrough. In this regard, the incision can be sized to permitpassage of only the shunt without any additional devices, or be sized topermit passage of the shunt in addition to additional devices, such asthe delivery device or an imaging device. In an embodiment, the incisionis about 1 mm in size. In another embodiment, the incision is no greaterthan about 2.85 mm in size. In another embodiment, the incision is nogreater than about 2.85 mm and is greater than about 1.5 mm. It has beenobserved that an incision of up to 2.85 mm is a self-sealing incision.For clarity of illustration, the drawing is not to scale and the viewinglens 1405 is not shown in FIG. 15A, although the applier can be guidedthrough one or more guide channels in the viewing lens. The applier 525can approach the suprachoroidal space from the same side of the anteriorchamber as the deployment location such that the applier does not haveto be advanced across the iris. Alternately, the applier can approachthe location from across the anterior chamber such that the applier isadvanced across the iris and/or the anterior chamber. The applier 525can approach the eye and the suprachoroidal space along a variety ofpathways. Various pathways for approaching the eye and deploying theshunt are described in detail below.

After insertion through the incision, the applier 525 is advancedthrough the cornea and the anterior chamber. The applier is advancedalong a pathway that enables the shunt to be delivered from the anteriorchamber into the suprachoroidal space. In one embodiment, the appliertravels along a pathway that is toward the scleral spur such that theapplier crosses through the scleral spur on the way to thesuprachoroidal space. The applier 525 can be pre-shaped, steerable,articulating, or shapeable in a manner that facilitates the applierapproaching the suprachoroidal space along a proper angle or pathway.

As mentioned, a guidewire can also be used to guide the applier or theshunt over the guidewire to the proper location in the eye. Theguidewire can be looped at a distal end to assist in makingsuprachoroidal dissection. Once the shunt is properly in place, the loopcan be released. If the shunt needs to be removed prior to releasing theloop, the guidewire loop can act as a retrieval mechanism. The loop canbe larger than the distal lumen opening of the shunt such that when theguidewire is pulled back, the loop pulls the shunt along with it.

The guidewire can be left in place even after the applier is removed.This enables the user to repeatedly access the site via the guidewirewithout having to relocate the site in the eye. A cannula can be used tocreate an access pathway to the delivery site. The delivery tool canthen be placed through the cannula. The cannula can remain fixed inplace with the viewing lens, and the end of the delivery device can bearticulated or steerable such that multiple shunts can be placed fromone access site. For example an infusion cannula from Dutch OphthalmicResearch Center (D.O.R.C.) can be used, in particular models that allowfor continuous infusion and aspiration to maintain a sufficient workingarea within the anterior chamber.

As discussed, the distal tip of the applier 525 can be sharp and canalso be tapered to facilitate a smooth penetration through the cornea.The distal tip of the shunt 105 can also be sharp. In addition, the tipof the applier device can be connected to an energy source ES, to allowenergy to be delivered to the tip of the applier body to assist increating the initial corneal stick, and in addition facilitating entryinto the suprachoroidal space through the scleral spur. In thisembodiment shown schematically in FIG. 15B, only the distalmost tip isexposed to apply energy to the tissue, and the remaining shaft of theapplier is insulated such as with a sleeve made of insulation material.Energy delivery wires are attaching to the applier shaft (such as viathe handle) to energize the tip portion, and such wires are alsoconnected to an energy delivery source ES and any required groundingpad. The energy that can be delivered to facilitate the procedure can beRF energy, laser energy, resistive heat energy or ultrasonic energy. Anenergy delivery system for medical use, such as those produced byStellertech Research (Mountain View, Calif.) can be employed, forexample, to apply RF energy to the tip of the applier. FIG. 16 shows anenlarged view of the anterior region of the eye showing the anteriorchamber AC, the cornea C, the iris I, the sclera S, and the choroid CH.The suprachoroidal space is at the junction between the sclera and thechoroid. The shunt 105 which is mounted on the applier 525, is shownapproaching the suprachoroidal space from the anterior chamber. Thedistal tip of the applier 525 moves along a pathway such that the distaltip is positioned at the scleral spur with the curve of the applier 525aiming the distal tip toward the suprachoroidal space. In this regard,the applier 525 and/or the shunt 105 can have a radius of curvature thatconforms to the radius of curvature of the suprachoroidal space. Thesurgeon can rotate or reposition the handle of the delivery device inorder to obtain a proper approach trajectory for the distal tip of theapplier, as described in further detail below.

The scleral spur is an anatomic landmark on the wall of the angle of theeye. The scleral spur is above the level of the iris but below the levelof the trabecular meshwork. In some eyes, the scleral spur can be maskedby the lower band of the pigmented trabecular meshwork and be directlybehind it. With the applier 525 positioned for approach, the applier 525is then advanced further into the eye such that the distal tip of theapplier and/or the shunt penetrates the scleral spur. The penetrationthrough the scleral spur can be accomplished in various manners. In oneembodiment, a sharpened distal tip of the applier or the shuntpunctures, penetrates, dissects, pierces or otherwise passes through thescleral spur toward the suprachoroidal space. The crossing of thescleral spur or any other tissue can be aided such as by applying energyto the scleral spur or the tissue via the distal tip of the applier 525.The means of applying energy can vary and can include mechanical energy,such as by creating a frictional force to generate heat at the scleralspur. Other types of energy can be used, such as RF laser, electrical,etc.

The applier 525 is continuously advanced into the eye, via thetrabecular meshwork and the ciliary body, until the distal tip islocated at or near the suprachoroidal space such that a first portion ofthe shunt 105 is positioned within the suprachoroidal space and a secondportion is positioned within the anterior chamber. In one embodiment, atleast 1 mm to 2 mm of the shunt (along the length) remains in theanterior chamber. FIG. 17 shows the distal tip of the applier 525positioned within the suprachoroidal space SS. For clarity ofillustration, FIG. 17 does not show the shunt mounted on the applier,although the shunt 525 is mounted on the applier during delivery. As theapplier 525 advances through tissue, the distal tip causes the sclera topeel away or otherwise separate from the choroid to expose thesuprachoroidal space.

One method of approach is to advance the applier 525 through the ciliarybody as it approaches the suprachoroidal space. The tissue of the sclerais structurally more tough than the ciliary body. As the distal tip ofthe applier 525 passes through the ciliary body and reaches the scleraltissue, the scleral tissue provides an increased resistance to passageof the applier 525 therethrough. Thus, the surgeon will detect anincrease in resistance to passage when the distal tip of the applierpasses through the ciliary body and reaches the sclera. This can serveas an indication that the distal tip of the applier has reached thesuprachoroidal space. In this regard, the distal region of the applier525 or the shunt can have a shape, such as a spade shape or a blunt end,that is configured to facilitate creating a dissection plan between thechoroid and the sclera and positioning of the distal region of theapplier in the suprachoroidal space. This thickness of this dissectionplane is approximately the same as the size of the device being placed.The distal region can be flexible or looped to allow for preferentialmovement into the space between the sclera and choroid.

As mentioned, the delivery device 510 and/or the shunt 105 can beequipped with navigational aides, such as radiopaque markers, or meansto enable ultrasonic visualization that assist in proper positioning ofthe applier and shunt in the eye. Once the applier 525 has been properlypositioned, the shunt 105 is advanced off of the applier 525, such as byactuating the implant advancing actuator 535 to move the advancingstructure 530 (FIG. 5) so as to push the shunt 105 off of the applierinto proper placement in the eye.

The shunt 105 can be deployed off of the applier in various manners. Forexample, as discussed above, the shunt can be pushed off the applier bymoving the advancing structure 530 (shown in FIGS. 5-6G) in the distaldirection. In an alternate method, the advancing structure 530 remainsstationary and the applier 525 is withdrawn in the proximal direction aswas described above with reference to FIGS. 6E-6G. This can method canbe advantageous as the shunt remains stationary during dismount from theapplier 525 rather than being moved during dismount. Thus, the shunt canbe properly positioned while still on the applier 525. In anothermethod, the applier is distally advanced into the suprachoroidal spacewhile the shunt remains stationary against the advancing structure 530.The advancing structure is then moved distally to push the shunt alongthe applier. The applier is then withdrawn into the advancing structureto uncouple the shunt from the applier.

The shunt can include structural features that assist in properplacement of the shunt, such as to ensure that the shunt 105 is notadvanced any further than necessary into the eye. For example, the shunt105 can include a structure, such as the proximal retaining member 1005(shown in FIG. 10), that abuts the scleral spur or another tissuestructure to prevent further movement of the shunt into the eye. FIG. 18shows a shunt 105 that is equipped with a skirt 1805 and FIG. 19 shows ashunt that is equipped with a pronged skirt 1810. As shown in FIG. 20,the skirt 1810 or 1805 abuts and anchors into the ciliary body toprevent the shunt 105 from being advanced any further into the eye.These features can further serve to prevent leakage of fluid around theoutside of the shunt. Previous efforts to increase the drainage of theanterior chamber by surgically creating a path between the anteriorchamber and the suprachoroidal space, known as cyclodialysis procedures,often caused too much drainage and low pressure (“hypotonia”) in theanterior chamber. Concern for excess flow and resultant hypotony can bea major reason why previous efforts have focused on placing shuntsthrough a scleral incision, so the sclera would surround at least aportion of the shunt to prevent flow around the shunt. Therefore, thesemeans for preventing flow around the outside of the shunt can proveessential in enabling placement of a shunt directly from the anteriorchamber to the suprachoroidal space without risk of hypotonia.

FIG. 21 shows the shunt 105 implanted in the eye so as to provide afluid pathway between the anterior chamber AC and the suprachoroidalspace SS. The shunt 105 was implanted by “tunneling” the shunt towardthe suprachoroidal space. That is, as the shunt is advanced toward thesuprachoroidal space, the distal tip of the applier and/or the shuntpenetrates the tissue and forms a tunnel through the eye tissue,initially the ciliary body. This differs from a procedure where theshunt is lowered into the eye via a scleral flap that is cut and foldedback for access to the implant location. In such a procedure, theimplanted shunt is positioned within a cavity that was formed by thefolded-back flap. However, in the procedure shown in FIG. 21, the shunt105 is substantially enclosed or surrounded by eye tissue in the regionbetween the anterior chamber and the suprachoroidal space. It alsodiffers from the procedure known as cyclodialysis, that in some casesentirely disinserts the ciliary body from the scleral spur to relievethe pressure in the anterior chamber, because essentially a puncture ismade and the shunt device that is placed, is left in the position of thepuncture.

Although FIG. 21 shows only a single shunt 105, it should be appreciatedthat multiple shunts can be implanted in the eye. The shunts can beimplanted end-to-end to form a single, elongate fluid pathway or aplurality of shunts can be positioned side-by side or spaced around thecircumference of the anterior chamber to form multiple fluid pathways.In addition, a single shunt can be implanted in an initial procedure andadditional shunts implanted in one or more subsequent procedures asneeded to establish or maintain optimal anterior chamber pressure.

If multiple shunts are used, it is not necessary that all of the shunts(or all openings in a shunt) be initially patent. This will allow thedrainage of aqueous humour to be initiated in a controlled manner byselectively opening additional shunts over a period of time. Over time,additional shunts can be activated (i.e., opened), such as by theinsertion of a stylet or other needle-type device, such as during anoffice visit. The shunts can also be opened or re-opened (if a shuntbecomes blocked after implantation) in various manners, such as using aphotochemical, laser, RF, ultrasound, or thermal procedure, orcombinations thereof. For instance, the shunt can have a single hole ormultiple holes along its proximal end or distal end, one or more ofwhich are initially covered by a second tube or other material. Applyinglight or other energy to the tube could cause the holes to open or couldcause the tube to shrink longitudinally, exposing additional openings toincrease flow.

In addition, the outer diameter of the shunt or the diameter of theinternal lumen can be varied by shrinking or enlarging the shunt usingthermal, light, or photochemical activation. For example, the shunt canbe initially relatively long and thin. Applying energy or otheractivation to the shunt could cause it to become shorter and/or largerin diameter, increasing its flow rate.

It is possible that the dissection formed by the shunt can cause a leakbetween the anterior chamber and the suprachoroidal space. In such acase, the leak can be filled or otherwise plugged with a material (suchas a foam or adhesive) or a structure (such as a gasket) that preventsleaking.

With reference still to FIG. 21, a spacer structure 2110 can optionallybe located on the proximal end of the shunt 105. The spacer structure2110 is a structure that extends outwardly from the shunt 105 to preventblockage of the proximal end of the shunt 105. With further reference toFIG. 21, the structure 2110 can also facilitates grasping the shunt inthe event it is necessary to remove the shunt.

In another embodiment, the shunt 105 is not positioned on the applier525 as the applier is advanced into the eye. In such a case, the handlecomponent 515 of the delivery instrument can be detached from theproximal end of the applier after the applier has been properlypositioned in the eye. The shunt 105 is then threaded over the applier,from the proximal end to the distal end, toward the delivery site.

In one implementation, a guide passageway is formed in the eye prior toadvancing the applier through the eye. The applier is then advancedthrough the previously formed passageway rather than using the applierto tunnel through the eye. The passageway can be formed in variousmanners, such as by using an energy source or phacoemulsificationequipment to form the passageway.

Additional Shunt and Delivery System Embodiments

Additional embodiments of the shunt 105 are now described. FIG. 22 showsa shunt 105 that includes an elongate core member 2205 that has one ormore external fluid flow features, such as flow channels 2210, locatedon its outer surface. The flow channel(s) 2210 define at least onepassageway for the flow of aqueous humour along the length of the shunt105. The configuration of the flow channel(s) 2210 can vary. In theembodiment of FIG. 22, a single flow channel 2210 having a helical orspiral configuration is located on the outer surface of the core member2205. The core 2205 can also include multiple spiral flow channels. FIG.23 shows another embodiment, wherein a plurality of straight orsubstantially straight flow channels are located on the external surfaceof the core member 2205. The shunt 105 can also include just a singlestraight flow channel or can include a combination of straight flowchannels and flow channels of various curvilinear configurations.

The core 2205 can be a solid piece of material that does not have aninternal lumen. A solid core 2205 can form a strong structure and cancreate a reliable flow path with a reduced risk of structural collapseor tissue ingrowth in the lumen. Alternately, the external flow channelscan be combined with an internal lumen that extends through the core2205. If the core 2205 is solid without an internal lumen, then it canbe delivered into the eye through a delivery lumen of a delivery device,such as through an applier. If the core 2205 includes an internal lumen,then the core can be delivered into the eye mounted over a deliverydevice, such as over an elongate applier.

The core 2205 can be manufactured in various ways. For example, the core2205 can be molded or can be extruded, such as from a biocompatiblematerial or any of the materials described herein. The core 2205 canalso be formed of a combination of different materials or can beco-extruded.

FIG. 24 shows a shunt 105 that includes an elongate outer member 2405,such as a stent, mounted over a plug member 2410. When this embodimentof the shunt 105 is implanted between the anterior chamber and thesuprachoroidal space, the plug member 2410 degrades over time, while theouter member 2405 does not degrade. The outer member 2405 remains in theeye to maintain a patent passageway between the anterior chamber and thesuprachoroidal space. The outer member 2405 can be solid (such as anelongate tube) or it can be a mesh. The outer member 2405 can beintegrally formed with the plug member 2410 or it can be embedded invarying degrees within the plug member to control the rate ofdegradation.

The degradation of the plug 2410 can be configured in various manners.For example, the rate of degradation of the plug can be based on theintraocular pressure such that the degradation rate increases as theintraocular pressure increases. Thus, a higher intraocular pressureresults in a greater rate of plug degradation than a lower intraocularpressure. In this manner, the rate of degradation of the plug can slowas the intraocular pressure approaches a predetermined value.

An exemplary way of implementing such a feature is to include aninternal lumen 2510 in the plug 2410, as shown in FIG. 25A. In aninitial state, the lumen 2510 has diameter of a reduced size such that alow level of aqueous humour flows through the lumen. The initial statecan correspond to the plug being exposed to an initially-highintraocular pressure. The high intraocular pressure causes the plug 2410to degrade such that the size of the lumen increases. As the size of thelumen increases (as shown in FIG. 25B), the level of aqueous humour flowthrough the lumen also increases, which results in a reduction inintraocular pressure and a reduction in the rate of degradation of theplug.

In an alternate embodiment of the device shown in FIG. 24, the stent2405 does not include an internal member. Thus, a stent 2405 isimplanted into the eye in a manner that maintains an opening between thesuprachoroidal space and the anterior chamber. The stent 2405 can be aself-expanding or balloon expanding stent that is expanded after it ispositioned within the eye. The stent 2405 can be for example a braidedor laser cut stent made of stainless steel or Nitinol.

The shunt can also be manufactured of a material that is absorbed intothe eye tissue after placement in the eye. Once absorbed, a spaceremains where the shunt was previously located. In this regard, theshunt can be manufactured of a complex carbohydrate or a collagen thatis non-inflammatory. In another embodiment, the shunt is covered with orfilled with a material that absorbed into the eye over time such as toprevent hypotony or to prevent a clot forming within the tube.

In the case of biodegradable or bioabsorbable devices, a variety ofmaterials can be used, such as biodegradable polymers including:hydroxyaliphatic carboxylic acids, either homo- or copolymers, such aspolylactic acid, polyglycolic acid, polylactic glycolic acid;polysaccharides such as cellulose or cellulose derivatives such as ethylcellulose, cross-linked or uncross-linked sodium carboxymethylcellulose, sodium carboxymethylcellulose starch, cellulose ethers,cellulose esters such as cellulose acetate, cellulose acetatephthallate, hydroxypropylmethyl cellulose phthallate and calciumalginate, polypropylene, polybutyrates, polycarbonate, acrylate polymerssuch as polymethacrylates, polyanhydrides, polyvalerates,polycaprolactones such as poly-ε-caprolactone, polydimethylsiloxane,polyamides, polyvinylpyrollidone, polyvinylalcohol phthallate, waxessuch as paraffin wax and white beeswax, natural oils, shellac, zein, ora mixture thereof, as listed in U.S. Pat. No. 6,331,313 to Wong, whichis expressly incorporated by reference in its entirety.

FIG. 26 shows another embodiment of the shunt that is formed of asponge-like flow member 2610 that is made of a porous material, such aspolyester material. The porous nature of the flow member 2610 forms oneor more fluid pathways for the flow of aqueous humour through the flowmember. The flow member 2610 can be formed of a material that can bepierced along its length by a wire or other structure. The piercingforms an internal lumen 2710 (FIG. 27) through which aqueous humour canflow. The internal lumen 2710 can be formed in the situation where it isdesired to increase the flow of aqueous humour through the flow member.

FIG. 28 shows another embodiment of the shunt 105 that includes a pairof anchor members 3305 located on opposite ends of the shunt. The anchormembers 3305 are sized and shaped to engage the eye tissue to retain theshunt 105 in a fixed or substantially fixed position within the eye. Theshunt 3305 includes an elongated central region on which are disposedone or more tines or teeth 3310 that are adapted to anchor with the eye.The anchor members 3305 and the teeth 3310 extend outwardly from theshunt 105 to define a space 3315 disposed along at least one side of theshunt 105 when the shunt 105 is positioned in the eye. The teeth can beoriented to extend at least partially into the trabecular meshwork suchthat the teeth form flow pathways into Schlemm's canal. The teeth 3310can be manufactured of various materials including silver or coated withsilver. Silver is a material that prohibits growth of surrounding tissuesuch that a space is retained around the shunt.

As discussed above with reference to FIG. 7, a distal or proximal end ofthe shunt 105 can be equipped with retaining structures. FIG. 29 showsan end region (distal and/or proximal) of the shunt 105 that includesslices that extend generally along the longitudinal direction of theshunt. The orientation of the slices can vary. For example, the slicescan extend longitudinally such that the slices define a plurality oflongitudinally-extending teeth that can interact with eye tissue toresist migration of the shunt 105. The slices can also be orientedtransverse to the longitudinal axis of the shunt. The end region can beflared outward to provide further resistance to migration.

In another embodiment, shown in FIG. 30, one or more sleeves 3405 arepositioned over the outer surface of the shunt 105. The sleeves 3405 canbe interspersed at various locations along the length of the shunt 105.In the embodiment of FIG. 30, a first sleeve 3405 is located on a distalregion of the shunt 105 and a second sleeve 3405 is located on aproximal region of the shunt 105. More than two sleeves can bepositioned on the shunt. The sleeves 3405 have an inner diameter thatpermits the sleeves to be fixedly mounted over the shunt. The outerdiameter of the sleeve is larger than the outer diameter of the shuntsuch that the sleeves form a raised surface on the shunt. The sleeves3405 can be annular such that the sleeves have an internal lumen thatfits entirely around the circumference of the shunt. Alternately, thesleeves 3405 are non-annular strips of material that are positioned onthe shunt such that they cover only a portion of the circumference ofthe shunt.

As an alternative or in addition to sleeves that are positioned over theshunt, the outer surface of the shunt can include grooves that aremachined or molded into the outer surface. The grooves can be a seriesof annular grooves or a single corkscrew groove that extends along thelength of the shunt. The grooves function to form alternating raised andlowered surfaces on the shunt. The shunt could also include pits orpockmarks on the outer surface.

The sleeves 3405 can have a smooth outer surface, an undulating outersurface, or can include one or more slices that can be oriented atvarious angles relative to the longitudinal axis of the shunt 105. Theslices form teeth in the sleeves 3405 to resist migration of the shunt.The sliced teeth can be biased outward such that the teeth flare outwardand engage adjacent tissue to prevent movement in either the proximal ordistal direction.

Any of the sleeves can also act as a marker to show the physician theproper shunt length to be inserted into the eye. Alternately, one ormore printed markers can be formed on the shunt outer wall or on thedelivery device. The markers can be BaSO₄ markers embedded in the shuntmaterial wall wherein the markers are made from an extruded polymercompounded with this radiopaque substance in the region of the desiredradiopacity. Further, the markers can be laser printed or etched on theshunt device to show the amount of shunt deployed in the suprachoroidalspace, or the amount by which the shunt device should be allowed toprotrude into the anterior chamber. The sleeves can be manufactured ofvarious materials. In one embodiment, at least one of the sleeves ismade of an anti-microbial silver material.

FIG. 31 shows another embodiment of the shunt 105 with sleeves 3605disposed on proximal and distal ends of the shunt. The sleeves 3605 haveslices that form arcs. The slices can be straight or they can becurvilinear. When the slices are located on the sleeves 3605 rather thanon the body of the shunt itself, the slices will not interfere withfluid flow through the lumen of the shunt. There is a risk that if theslices are on the shunt itself, an ingrowth of tissue into the slicescan result. Such an ingrowth can interfere with the flow of fluidthrough the shunt's internal lumen. Advantageously, the sleeves permitthe use of slices that do not interfere with the internal lumen of theshunt. The slices on the sleeves create retention means on both ends ofthe shunt. The slices are biased toward each other so that micromotionof the shunt is prevented. As a force acts upon the shunt to force theshunt either further into the suprachoroidal space or into the anteriorchamber, the slices begin to extend axially from the longitudinal axisof the inner lumen causing a restriction of movement of the shunt ineither direction.

FIG. 32 shows yet another embodiment of the shunt 105. In thisembodiment, a retention structure, such as a coil 3705, is located onthe outside of the shunt 105. The coil 3705 can be formed of a wire thatis wrapped around the outer surface of the shunt. The coil 3705functions to retain the shunt 105 within the eye. In some embodiments,the coil 3705 can also be sized and shaped such that it forms a conduitor flow path that directs fluid to flow along the outside of the shunt.The retention structure need not be coil shaped but can rather havevarious shapes and sizes adapted to retain the shunt in place. Forexample, the retention structure can be a straight wire that extendsalong the length of the shunt and that is raised relative to the outersurface of the shunt. The wire can have various dimensions. In oneembodiment, the wire has a diameter of 0.0005 inch.

It can be desirable to position one or more structures on the shunt thatcan be grasped, such as to reposition the shunt or remove the shunt fromthe eye. Some embodiments of the shunt that include removal orrepositioning structures are now described. The removal or repositioningstructure can be any structure on the shunt that can be grasped in orderto move or remove the shunt. For example, the removal structure can bean enlarged region, a raised region, or a region of reduced diameterthat provides a location that can be grasped by a removal tool. Theretention elements described above can also serve as a grasping elementfor removal or moving of the shunt.

FIG. 33A shows an embodiment of the shunt 105 that includes a graspingloop 3805 on the proximal end of the shunt. The grasping loop 3805 isshaped such that it can be grasped by a removal tool or a repositioningtool. The grasping loop 3805 can be connected to a coil member 3810 thatextends entirely or partially along the length of the shunt 105 suchthat when the grasping loop is pulled, the shunt undergoes a radialreduction in size, as shown in FIG. 33B. The shunt can also includeouter thread structures that permit the shunt to be screwed into thesuprachoroidal space by rotating the shunt in one direction and thenscrewed out by rotating in an opposite direction. The threads can grasponto the surrounding tissue to provide counter traction when thegrasping loop 3805 is pulled. The shunt 105 can also be formed of abraided shaft with a distal grasping loop 3805, as shown in FIG. 34.

FIG. 35 shows another embodiment of an elongate device 4002 with a snare4005 located on a proximal end. The device 4002 can be positioned withina lumen of the shunt such that the snare 4005 is compressed within thelumen. In use, the device 4002 is pulled partially out of the lumen suchthat the snare 4005 expands to form a loop that can be grasped by aremoval or repositioning tool.

In another embodiment, shown in FIG. 36, the shunt 105 includes a distalregion 4105 that is flat and thin so as to have a spatula-like shape.The flat and thin configuration of the shunt is adapted to facilitatepenetration of the eye and to facilitate peeling of the choroid from thesclera and positioning of the distal region of the applier in thesuprachoroidal space. The shunt includes an internal lumen for thepassage of a guidewire or through which fluid or visco-elasticsubstance(s) can be passed to assist dissection or visualization. Inaddition, a fiber optic can also be passed through the lumen to assistdirect visualization of the treatment region as desired during placementor repositioning of the shunts.

As discussed, the shunt 105 can be shaped or otherwise configured so asto minimize the risk of trauma to the eye during delivery or duringmicromotion of the shunt after the shunt has been delivered. Forexample, any region of the shunt can have an atraumatic shape or can bemanufactured of or coated with a soft material. In one embodiment, shownin FIG. 37, an atraumatic tip 4205 is located on the proximal region ofthe shunt 105. The tip 4205 can be shaped in an atraumatic manner, suchas by having a rounded end. The tip 4205 can be manufactured of amaterial that is softer than the remainder of the shunt or can bemanufactured of the same material. The atraumatic tip 4205 is adapted toprotect against damage to the cornea in the event of corneal contact ormicromotion of the shunt. In one embodiment, at least a portion of theshunt includes a silicone sleeve that at least partially covers theouter surface of the shunt. The silicone sleeve can be formed by dippingthe shunt into a silicone solution.

FIG. 38 shows another embodiment wherein the shunt 105 includes aresilient region 4305. The resilient region can be formed in variousmanners. For example, in one embodiment, the resilient region is formedby either a reinforced region of silicone tube or by a separateresilient element such as a spring. In another embodiment, the resilientregion 4305 is corrugated to provide flexibility. The spring can beformed of various materials, including polyimide and stainless steel.Any of the embodiments of the shunt described herein can include aresilient region along a portion of its length or can be resilient alongits entire length. In addition, the shunt can be flexible along itsentire length, can have a predetermined stiffness along its entirelength or can have a stiffness that varies along its length.

As discussed above with reference to FIGS. 22 and 23, the shunt can beformed without an internal lumen and configured such that the flowoccurs along the outer surface of the shunt. FIG. 39 shows anotherembodiment of a shunt 105 that does not have an internal lumen. Theshunt 105 has a plurality of extensions 4405 that extend radiallyoutward from a central core. The extensions 4405 define elongatedgrooves that extend along the length of the shunt. The elongated groovesserve as flow pathways to guide fluid flow along the length of theshunt. The embodiment of FIG. 39 has four extensions although thequantity of extensions can vary. A material, such as silver, can bepositioned or coated within the grooves to keep the channels open and toprovide increased distribution area for fluid flow. As mentioned, silverserves to inhibit or prevent tissue growth.

As shown in FIG. 40A, the peripheral edges of the extensions 4405 canhave grooves or other structures that are adapted to retain or anchorthe shunt within the eye. In the embodiment shown in FIG. 40B, the shunt105 has extensions 4405 and a central core with an internal lumen 4407that can be used to mount the shunt on a delivery device. The centrallumen 4407 can also be used for the flow of fluid through the shunt.

The shunt can include features that are adapted to modify or enhance theflow of fluid through or along the shunt, such as after the shunt hasbeen placed in the eye. In one embodiment, shown in FIG. 41, the shunt105 has one or more holes that 4605 that communicate with the internallumen. The holes are initially plugged with a material such that flowcannot occur through the holes. After placement of the shunt in the eye,the holes can be unplugged, such as by inserting an instrument throughthe holes or applying energy to the location where the holes are to beformed. The holes can also unplug automatically by plugging the holeswith a material that degrades upon placement in the eye or that degradesafter a period of time.

FIG. 42A shows a cross-sectional view of a portion of another embodimentof the shunt 105. In this embodiment, the shunt 105 includes a narrowedregion 4705 such that the internal lumen 4710 is at least partiallyblocked in the narrowed region 4705. As shown in FIG. 42B, the narrowedregion 4705 can be opened or expanded at a desired time, such as throughapplying heat to the narrowed region 4705 to cause the narrowed regionto expand such that the internal lumen is no longer blocked. The regioncan then be narrowed again by further application of heat if desired.The narrowed region can also be opened and closed by tying abiodegradable band or suture around the narrowed region. The sutures canerode over a time period so that the narrowed region gradually opensover time.

FIG. 43 shows another embodiment of the shunt 105 that includes one ormore valved regions 4907 along the length of the shunt. The valvedregions 4907 serve to regulate the flow of fluid through the internallumen. Each of the valve regions 4907 can include a separate valvestructure or can be shaped to regulate fluid flow. For example, thevalved regions can have an expanded size that permits more fluid flow orcan have a reduced size that limits fluid flow. The valved regions canbe colored so as to respond to different colors of laser light dependingon a desired result.

FIG. 44 shows an embodiment of the shunt 105 that includes a bulbouselement 4905 that is radially larger than the remainder of the shunt.The bulbous element 4905 can be fixed in the enlarged state or it can beadapted to transition from a reduced-size state to the enlarged-sizestate. For example, the bulbous element 4905 can be an expandableballoon or it can be an expansion members 910 such as was describedabove in FIG. 9A. The bulbous element 4905 can include holes thatcommunicate with the internal lumen of the shunt 105 to permit ingressand egress of fluid.

FIG. 45 shows another embodiment of the shunt 105 wherein the bulbouselement 4905 is located between the proximal and distal ends of theshunt 105. Thus, the shunt 105 includes a central bulbous element 4905with proximal and distal regions of reduced radial size relative to thebulbous element. The shunt 105 can also include a plurality of bulbouselements that are interspersed along the length of the shunt.

The use of the shunt 105 with the bulbous element 4905 is now describedwith reference to FIGS. 46 and 47, which show two embodiments of thebulbous element shunt positioned in the suprachoroidal space SS. Asshown in FIGS. 46 and 47, the shunt 105 is positioned such that aproximal end communicates with the anterior chamber AC and the bulbouselement 4905 is positioned in the suprachoroidal space. The enlargedbulbous region 4905 forms a space or “lake” for accumulation of fluidwithin the suprachoroidal space. Because the lake is contained entirelywithin the suprachoroidal space and enclosed by tissue, the lake is notprone to infection and other complications. The lake can also be formedusing an embodiment of the shunt that does not have a bulbous element. Afluid can be flowed into the suprachoroidal space through the internallumen of the shunt. The fluid fills accumulates within thesuprachoroidal space to form the lake.

In another embodiment, the lake is formed via hydro-dissection. Adelivery cannula can be positioned in the eye such that fluid can beflowed into the suprachoroidal space via the cannula. The fluid isflowed into the eye with a pressure sufficient to form a dissectionplane within the suprachoroidal space. The fluid can then accumulatewithin the suprachoroidal space so as to form a lake.

FIG. 48 shows an embodiment of the shunt 105 that includes a distal tipmember 5305 that is integrally formed with the shunt. The tip member5305 has a shape that is adapted to facilitate dissection into thesuprachoroidal space. For example, the tip member 5305 can be “bullet”shaped in that the diameter of the tip member 5305 gradually reducesmoving along the distal direction. The tip member 5305 can include oneor more holes that communicate with the internal lumen of the shunt.Alternately, the tip member 5305 can be without holes and holes can beplaced on the side of the shunt 105. The tip member 5305 can bemanufactured of various materials, including stainless steel.

FIG. 49 shows an embodiment of a shunt 105 that mounts over a mandrel5405, which can be a portion of the applier 525 such that the mandrel5405 can be incorporated into the delivery system. The shunt 105 isadapted to conform to the shape of the mandrel 5405 when it is mountedon the mandrel, such as during delivery of the shunt 105. When themandrel 5405 is removed, the shunt 105 transitions to a different shape.The shunt 105 can be at least partially manufactured of a shape-memorymaterial to accomplish the change in shape. In one embodiment, one ormore Nitinol rings are disposed on the shunt wherein the rings undergo ashape change to induce the shunt to transition in shape. A Nitinol wirecan also be threaded along the length of the shunt to induce the shapechange.

Different regions of the shunt 105 can transition to different shapes.For example, the shunt 105 can include a proximal region 5410 that issubstantially round when the mandrel 5405 is positioned within theshunt. When the mandrel 5405 is removed from the shunt, the proximalregion 5410 radially reduces in size while the remainder of the shuntremains the same shape, as shown in FIG. 50. The proximal region 5410can taper in size when the mandrel is removed such as to limit or meterflow through the shunt. In addition, the proximal tip of the shunt canflatten to an oval shape while the remainder of the shunt remains round.Alternately, the proximal tip can remain round but of a reduce diameterrelative to the remainder of the shunt.

When the mandrel is removed, the shunt 105 can transition to a shapethat is particularly suited for placement and delivery into thesuprachoroidal space. For example, with reference to FIG. 51A, the shunt105 can include a first region 5605 that transitions to a first contouror first radius of curvature and a second region that transitions to asecond contour or second radius of curvature. FIG. 52 shows the shunt ofFIG. 51 positioned in the eye. The first region 5605 has a first radiuscurvature that complements the radius of curvature of the suprachoroidalspace. The second region 5610 has a second radius of curvature that istighter than the first radius such that the proximal tip of the shunt isdirected away from the cornea C and toward the anterior chamber AC. Thisreduces the likelihood that the proximal tip of the shunt 105 willcontact the cornea after placement of the shunt.

FIG. 51B shows another embodiment of a shunt 105 that has a stapleshape. The shunt 105 includes a pair of legs 5615 a and 5615 b that areconnected by a connecting member 5620. In an embodiment, both of thelegs 5610 have an internal lumen with a distal opening 5625 for inflowor outflow of fluid. The legs 5615 also have one or more proximalopenings. The proximal openings can be located at the location where thelegs connect to the connecting member 5620. Alternately, the connectingmember 5620 can also have an internal lumen that communicates with theinternal lumens of the legs 5615. The connecting member 5620 can includeone or more openings that communicate with the internal lumens forinflow or outflow of fluid. In another embodiment, only one of the legs5615 has an internal lumen while the other leg is solid and serves as ananchoring member.

In use, the shunt 105 of FIG. 51B is positioned in the eye such that thedistal opening 5625 of each leg 5615 communicates with thesuprachoroidal space and the connecting member is positioned is locatedin the angle between the iris and the cornea. One or both of the legs5615 provides a fluid passageway between the suprachoroidal space andthe anterior chamber. If one of the legs 5615 does not include aninternal lumen, then the non-lumen leg can serve as an anchor thatsecures the shunt 105 in a fixed position in the eye.

FIG. 51C shows another embodiment of a shunt 105. This embodimentincludes a partially-annular connecting member 5640 and a plurality oflegs 5645. The connecting member 5640 is partially annular in that itextends over a range of less than 360 degrees. For example, theconnecting member 5640 can extend from about twenty degrees to greaterthan 180 degrees. The connecting member 5640 and the legs 5645collectively reside within a curved plane that conforms to the curvatureof a dissection plane that includes the suprachoroidal space. One ormore of the legs 5645 can include an internal lumen that communicateswith an inflow and outflow openings. In use, the shunt 105 of FIG. 51Cis positioned in the eye such that the connecting member 5640 sitswithin the angle between the iris and the cornea, while the legs 5645extend into the suprachoroidal space. The legs 5645 can serve as fluidconduits and/or as anchors for securing the device in the eye.

Further Description of Methods

There are various pathways of approach for delivering the shunt into theeye using the delivery system such as the system shown in FIG. 6B. FIG.53 shows a schematic, front view of the upper region of a patient's faceincluding the two eyes. For reference purposes, the eyes are showndivided into four quadrants I, II, III, and IV when viewed from thefront of the eye. For each eye, the quadrants I and III are located onthe lateral side of the eye and the quadrants II and IV are located onthe medial side of the eye. In one embodiment, the approach pathwaypasses through only a single quadrant. In other embodiments, the pathwaypasses through at least two quadrants, at least three quadrants, orthrough all four quadrants. In an exemplary shunt delivery embodiment,the surgeon delivers the shunt with the shunt initially approaching theeye from quadrant I or IV such that the corneal incision is withinquadrant I or IV. In another shunt delivery embodiment, the shuntapproaches the eye from quadrant II or III. As described below, thelocation where the shunt is implanted in the suprachoroidal space can beat various locations relative to the location of the incision. In anembodiment, the location where the shunt is implanted in thesuprachoroidal space is from 0 degrees to 180 degrees from the incisionlocation. For example, the incision can be in quadrant I and the implantlocation is 180 degrees away in quadrant III. In another embodiment, theincision location and implant location are separated by at least 90degrees or up to 90 degrees. The actual placement of the shunt can be inany quadrant depending on the shape of the tip of the applier.

FIGS. 54A and 54B shows perspective and plan views, respectively, of anexemplary delivery pathway 5701 of the applier and shunt duringimplantation of the shunt into the eye. The delivery pathway 5701 beginsat an incision location 5702 and moves toward dissection location 5703where the shunt dissects the scleral spur and approaches thesuprachoroidal space.

In one embodiment, the incision location 5702 is along the axis thatseparates quadrants I and IV (i.e., at the “9 o'clock” or “3 o'clock”position of the eye) and the dissection location 5703 is approximately90 degrees from the incision location (i.e., at the “12 o'clock”position of the eye). Such a delivery pathway is transcorneal in that ittraverses over the cornea. However, the delivery pathway need not betranscorneal. FIGS. 55A-55D show the delivery system and attached shunttraveling along the previously described delivery pathway. In FIG. 55A(front plan view) and FIG. 55B (perspective view), the delivery system515 is in an initial approach position relative to the eye such that thedistal end of the applier 525 is at the incision and about to penetrateinto the eye. If the applier 525 is curved, the line of curvature of theapplier 525 can be in various orientations. In one embodiment, theapplier's line of curvature is initially oriented such that thecurvature moves away from the interior of the eye.

With reference now to FIG. 55C (front plant view) and FIG. 55D(perspective view), the applier and shunt have passed over the corneasuch that the distal tip of the applier has passed through the anteriorchamber and is at or near the scleral spur. During such passage, thehandle of the delivery system is rotated and translated to align theapplier's curvature with the curvature of the suprachoroidal space. Thetip of the applier 525 is then advanced and passed through the scleralspur to position the shunt 105 within the suprachoroidal space.

FIG. 56 shows an alternative transcorneal delivery pathway 5701 whereinthe incision location 5702 and the dissection location 5703 areapproximately 180 degrees from one another. FIGS. 55A, 55B, and 57 showthe delivery system and attached shunt traveling along such a deliverypathway. In the initial approach orientation, the delivery system 510 ispositioned such that the tip of the applier 525 is at the incisionlocation (such as shown above in FIGS. 55A and 55B). The handlecomponent 515 is translated and/or also rotated such as approximatelyninety degrees so that the distal tip of the applier 525 resides withina plane that intersects the scleral spur. The line of curvature of theapplier 525 is not yet necessarily aligned with the curvature of the eyein quadrant I. In addition, the applier is still positioned at or nearquadrant I.

With reference now to FIG. 57, the delivery system 510 is translatedsuch that the distal tip of the applier 525 moves near or into quadrantIV. The translation can occur either by translating the handle component510 or by causing the advancing member 530 and applier 525 to elongate.In conjunction with the translation, the handle component 510 is rotatedto re-orient the applier 525 such that the line of curvaturesubstantially aligns with the curvature of the eye, specifically thecurvature of the dissection plane, which extends through thesuprachoroidal space. At this stage, the tip of the applier is directedtoward the scleral spur and the line of curvature extends toward thesuprachoroidal space. The applier 525 can then be distally advanced intothe suprachoroidal space and the shunt dismounted from the applier so asto place the shunt in or near quadrant IV.

As mentioned, the delivery system 510 can approach the eye in othermanners than described above. In another embodiment, the incisionlocation and the dissection location are within the same quadrant. Insuch an embodiment, the distal tip of the applier passes through anincision in the cornea that is closer to the scleral spur, rather thanfrom across the eye as in the previously-described embodiments. FIGS.58A-58D show an example of such a delivery pathway. In FIG. 58A (planview) and FIG. 58B (perspective view), the delivery system 510 in aninitial approach position (such as in quadrant I). The line of curvatureof the applier 525 is not yet aligned with the curvature of the eye. Thedelivery system is translated so that the applier 525 penetrates theeye. The handle component 510 is then rotated such that the applier isdirected toward the scleral spur and the line of curvature extendstoward the suprachoroidal space, as shown in FIG. 58C (plan view) andFIG. 58D (perspective view). The applier 525 can then be distallyadvanced through the scleral spur and into the suprachoroidal space. Thewhole procedure occurred with the applier being positioned in a singlequadrant. The delivery system 510 can be used to approach the eye fromvarious approach angles so as to position multiple shunts 105 around thecircumference of the eye, as shown in FIG. 58D. The shunts 105 can beinterspersed or grouped in clusters around the entire circumference or aportion of the circumference of the eye.

A further embodiment is one where multiple shunts are loaded into adelivery system and able to be delivered into various locations aroundthe anterior chamber to the suprachoroidal space in a fashion such thatthe delivery device is not removed from the anterior chamber. The deviceis moved throughout the anterior chamber and has a multi-fire chambersuch that as one shunt is delivered from the applier 525, another shuntis loaded onto the applier 525 and so on. This allows multiple shuntplacements without reloading or using another device.

Infusion

During the procedure, fluid can be infused into the eye in order tostabilize the pressure in the anterior chamber, such as prior to,during, or after installation of a shunt. Infusion can also be used tomaintain a clear field of view along the delivery pathway duringdelivery of the shunt. There is a risk that the pressure within theanterior chamber can adversely drop due to loss of fluid, which canpossibly result in collapse of the anterior chamber. In order to countera drop in pressure, fluid can be infused into the anterior chamber inorder to maintain the pressure within a desired range. The fluid can beinfused through a dedicated internal lumen in the applier or infusedthrough the lumen in the shunt. The fluid can also be infused through aseparate system that interfaces with the eye. For example, a cannulizedmember can be inserted into the anterior chamber and coupled to a sourceof fluid, such as a bag or saline or other biocompatible fluid source.If the pressure within the anterior chamber drops below a thresholdvalue, the resulting pressure differential can cause fluid toautomatically flow into the anterior chamber through the cannulizedmember.

A dye can be infused into the eye in order to provide visualization. Thedye can be viewable through a visualization instrument. As the dye flowsinto the suprachoroidal space, it provides a visualization of flow. Thedye can be photoactivated such that it shows aqueous humor dispersionwhen a certain type of light is applied to the dye. In addition, anultrasound or Doppler can be used (such as by integrating a Doppler tipon the delivery device) to visualize or sense flow, or the rate of flow,through the suprachoroidal space.

Shunts in Use with Closed Angle Glaucoma

With reference to FIG. 59, it is possible for aqueous humor toaccumulate within the posterior chamber PC such that at least a portionof the iris I is forced upward into the anterior chamber. Due to thepressure in the posterior chamber, the iris can angle toward the corneaso as to form a crest and then fall back toward the posterior chamber.In such a case, the base of the iris might interfere with or block theopening on the proximal end of the shunt. A shunt 105 can be used havingan elongated length or extension 6205 that repositions the proximal endof the shunt 105 to a location that is not blocked or interfered with bythe iris. For example, as shown in FIG. 59, the extension 6205 is sizedand positioned such that a proximal end 6210 is positioned over thecrest of the iris. The extension 6210 can be made of a soft or flexiblematerial so as to minimize or eliminate the risk of damage to the corneashould the proximal end 6210 contact the cornea. In another embodiment,shown in FIG. 60, the extension 6205 has a curved shape such that thedistal end 6210 is angled away from the cornea.

FIG. 61 shows another embodiment wherein the shunt extends through theiris I such that the proximal end 6210 and the internal lumen of theshunt communicate with the posterior chamber. The shunt permits aqueoushumor to flow out of the posterior chamber to release pressure in theposterior chamber. The shunt 6205 can extend through various locationsof the iris and can be manufactured of a material that is compliant,such as silicone. The embodiment shown in FIG. 61 can be used in placeof or to conjunction with an iris iridoplasty procedure. In addition,the delivery system can be adapted such that a distal end of the applierhas a tip, such as an RF tip as described in more detail above, that isadapted to perform an iridoplasty without the use of the shunt.

Trans-Scleral Delivery of Shunt

In the previously-described embodiments, the shunt 105 is delivered bypassing the shunt through a corneal incision or puncture. The surgeonthen passes the shunt through the anterior chamber, across the scleralspur, and into the suprachoroidal space. In another embodiment, thesurgeon makes an incision in the sclera to provide a trans-scleraldelivery of the shunt into the eye. After making the scleral incision,the surgeon passes the proximal end of the shunt through the scleralincision sclera into suprachoroidal space. The surgeon then pushes theshunt toward the anterior chamber, such as via the scleral spur, untilthe proximal region of the shunt is positioned in the anterior chamberand the distal region of the shunt is positioned in the suprachoroidalspace.

The trans-scleral approach is described in more detail with reference toFIGS. 62 and 63. FIG. 62 shows the delivery device 510 positioned suchthat the distal tip of the applier 525 or the shunt 105 itself canpenetrate through an incision in the sclera. The applier 525 or shunt105 can be used to make the incision or a separate cutting device can beused.

After the incision is formed, the applier 525 and attached shuntadvances through the sclera and into the suprachoroidal space. Thesurgeon advances the applier 525 until a proximal region of shunt 105 ispositioned within the anterior chamber and a distal region is within thesuprachoroidal space, as shown in FIG. 63. The surgeon then releases theshunt 105 off of the applier 5252 so that the shunt provides a fluidpassageway between the anterior chamber and the suprachoroidal space. Inone embodiment, the applier 525 travels along a pathway from thesuprachoroidal space toward the scleral spur such that the appliercrosses through the scleral spur on the way to the anterior chamber. Theapplier 525 can be pre-shaped, steerable, articulating, or shapeable ina manner that facilitates the applier passing through the suprachoroidalspace along a proper angle or pathway.

As discussed above, various devices can be used to assist in guiding thedelivery device and shunt into a proper position in the eye. Forexample, a guidewire can be used to guide the applier or the shunt overthe guidewire to the proper location in the eye. The guidewire or thedelivery can be equipped with a fiber optic that provides directvisualization of the eye during delivery of the shunt. In anotherembodiment, one or more imaging systems can be used during deliver ofthe device. Such imaging systems can include, for example, ultrasound(UBM), optical coherence tomography (OCT), and endoscopic viewing. OCTperforms cross-sectional imaging of internal tissue microstructure bymeasuring the echo time delay of backscattered infrared light using aninterferometer and a low coherence light source. For example, theVisante® OCT system from Zeiss Medical (Germany) can be used tonon-invasively image during placement of the implants, or to confirmplacement once the shunt has been place, post procedure and also atfollow up. In addition, certain ultrasonic systems and those providingenhanced tactile feedback or ultrasonic guidance can be used, forexample devices shown in U.S. Pat. Nos. 6,969,384 and 6,676,607,incorporated by reference herein in their entirety, Endoscopes, such asthe i-Scope™, and UBM devices (high frequency ultrasound) can be usedsuch as those made by Ophthalmic Technologies, Inc. (Ontario, Canada).

In another embodiment, the shunt is deployed into the eye in combinationwith a cataract treatment procedure. In a cataract treatment procedure,the surgeon makes an incision in the cornea and inserts a viscoelasticmaterial into the eye through the incision. The surgeon then removes thecataract through the incision. In combination with such a procedure, thesurgeon implants a shunt 105 into the eye in the manner described above.A new lens can be implanted into the eye pursuant to this procedure. Theshunt can be implanted either before or after removal of the lens.

Although embodiments of various methods and devices are described hereinin detail with reference to certain versions, it should be appreciatedthat other versions, embodiments, methods of use, and combinationsthereof are also possible. Therefore the spirit and scope of theappended claims should not be limited to the description of theembodiments contained herein.

What is claimed:
 1. An ocular implant system, comprising: (a) an ocularimplant, comprising: a tube having a proximal region, a distal region,and an internal lumen formed by an annular wall, wherein the tube has atleast one ingress to the internal lumen that communicates with theanterior chamber of the eye when the tube is positioned in the eye in adeployed location and at least one egress from the internal lumen thatfluidly communicates with the suprachoroidal space when the tube ispositioned in the eye in the deployed location, wherein the at least oneegress includes at least one opening in the distal region of the tube;and (b) a delivery instrument defining a longitudinal axis andcomprising: (i) a hand-held component operatively coupled to anelongated member, the handheld component coupled to an actuator that canbe actuated to move the elongated member in a proximal directionrelative to the ocular implant, (ii) the elongated member having adiameter and cross-sectional shape configured to be inserted through theinternal lumen of the ocular implant such that the ocular implant isremovably coupled to the elongated member, the elongated membercomprising: a proximal region aligned along the longitudinal axis of thedelivery instrument; a distal region curved away from the longitudinalaxis; and a distal tip that forms the distal-most portion of thedelivery instrument when the ocular implant is removably coupled to theelongated member during delivery through an anterior chamber, whereinthe distal tip is configured to bluntly dissect eye tissue; and (iii) adeployment structure aligned along the longitudinal axis of the deliveryinstrument between a proximal end and a distal end of the deploymentstructure, wherein the proximal end is coupled to the hand-heldcomponent and the distal end is positioned around the elongated memberat a location proximal of the ocular implant when the distal region ofthe elongated member is inserted through the ocular implant, wherein thedelivery instrument is configured to: introduce the ocular implantthrough the cornea of the eye while the delivery instrument and theocular implant remain fixed relative to one another, advance the ocularimplant through the anterior chamber while the entire deliveryinstrument and the ocular implant remain fixed relative to one another,dissect at least a portion of the ciliary body from the sclera at alocation proximate a sclera spur using the distal tip of the elongatedmember to form a dissected tissue plane between the ciliary body and thesclera while the delivery instrument and the ocular implant remain fixedrelative to one another, advance the ocular implant toward thesuprachoroidal space through the dissected tissue plane while the entiredelivery instrument and the ocular implant remain fixed relative to oneanother, and withdraw the elongated member into the distal end of thedeployment structure so as to uncouple the ocular implant from theelongated member and into the deployed location as a result of actuationof the actuator causing the elongated member to move in a proximaldirection while the ocular implant remains substantially fixed in placerelative to eye tissue, wherein the distal region of the elongatedmember is flexible relative to the deployment structure such that thedistal region conforms to the longitudinal axis of the deliveryinstrument when withdrawn into the deployment structure.
 2. An implantas in claim 1, wherein the at least one opening in the distal region ofthe tube comprises an opening located at a distal-most end of the tube.3. An implant as in claim 2, wherein the at least one opening in thedistal region of the tube comprises a plurality of side openingsinterspersed along a side of the tube.
 4. An implant as in claim 3,wherein the tube includes a series of annular grooves, wherein all ofthe side openings are located distal of the series of annular grooves onthe tube.
 5. An implant as in claim 4 wherein the at least one openingin the distal region of the tube comprises a plurality of side openingsinterspersed along a side of the tube, wherein all of the side openingsare located distal of the series of annular grooves on the tube.
 6. Animplant as in claim 1, wherein the at least one opening in the distalregion of the tube comprises a plurality of side openings interspersedalong a side of the tube.
 7. An implant as in claim 1, wherein the atleast one opening in the distal region of the tube comprises an openinglocated at a distal-most end of the tube, and wherein the tube includesa series of annular grooves that form alternating raised and loweredsurfaces along at least a portion of the length of the tube.
 8. Animplant as in claim 1, wherein the at least one ingress comprises anopening in the proximal-most end of the tube at least partiallysurrounded by an annular flange formed by the first region of increasedwall thickness, and the at least one opening in the distal region of thetube comprises an opening on a distal-most end of the tube.
 9. Animplant as in claim 8, wherein the at least one opening in the distalregion of the tube further comprises a plurality of side openingsinterspersed along a side of the tube.
 10. An implant as in claim 1,wherein the tube has a circular cross-sectional shape.
 11. An implant asin claim 1, wherein the tube has an oval cross-sectional shape.
 12. Animplant as in claim 1, wherein the at least one opening in the distalregion of the tube is positioned in the supraciliary space when theimplant is positioned in the eye.
 13. An implant as in claim 12, whereinthe first region of increased wall thickness comprises an annular flangethat is located in the anterior chamber when the implant is positionedin the eye.
 14. An implant as in claim 13, wherein 1 mm to 2 mm of aproximal length of the tube is located in the anterior chamber when theimplant is positioned in the eye.
 15. An implant system as in claim 1,wherein the elongated member is configured to be inserted through theinternal lumen of the ocular implant such that a distal end of theelongate member extends beyond a distal end of the ocular implant. 16.An implant system of claim 15, wherein the ocular implant comprises asecond shape that is different from a first shape of the elongatedmember, wherein at least one of the first shape and the second shapechanges when the elongated member is inserted through the internal lumenof the ocular implant.
 17. An implant system of claim 1, wherein thedelivery instrument is configured to position the ocular implant at thedeployed location without a sheath surrounding at least a portion of thetube.
 18. An implant system of claim 1, wherein only the elongatedmember retracts to uncouple the ocular implant from the deliveryinstrument.
 19. An implant system of claim 1, wherein the self-sealingcorneal incision comprises an opening in the cornea that is no greaterthan 2.85 mm in size.
 20. An implant system of claim 1, wherein thelongitudinal axis is straight.
 21. An ocular implant system, comprising:(a) an ocular implant, comprising: a tube having a proximal region, adistal region, and an internal lumen, wherein the tube has at least oneentrance to the internal lumen that communicates with the anteriorchamber of an eye when the tube is positioned in the eye in a deployedlocation and at least one exit from the internal lumen that fluidlycommunicates with the suprachoroidal space when the tube is positionedin the eye in the deployed location to permit aqueous to flow throughthe lumen from the anterior chamber toward the suprachoroidal space; aflange extending at least partially around a proximal end of the tube,wherein the flange at least partially surrounds the at least oneentrance to the internal lumen; and (b) a delivery instrument defining alongitudinal axis and comprising: (i) a hand-held component having anactuator; (ii) an elongated member operatively coupled to the handheldcomponent, the elongated member comprising: (1) a proximal regionaligned along the longitudinal axis of the delivery instrument; (2) adistal region shaped to curve away from the longitudinal axis; and (3) adistal tip that forms the distal-most portion of the delivery instrumentduring introduction of the ocular implant into the anterior chamber, thedistal tip configured to bluntly dissect eye tissue; and (iii) adeployment structure having a proximal end coupled to the hand-heldcomponent and a distal end aligned along the longitudinal axis andpositioned around the elongated member at a location proximal of theocular implant when the ocular implant is removably attached to thedelivery instrument, wherein the distal region of the elongated memberis flexible relative to the deployment structure and is configured towithdraw in a proximal direction relative to the ocular implant into thedistal end of the deployment structure and conform to the longitudinalaxis of the delivery instrument to uncouple the ocular implant from theelongated member at the deployed location as a result of actuation ofthe actuator causing the elongated member to move in a proximaldirection while the ocular implant remains substantially fixed in placerelative to eye tissue.
 22. An implant system as in claim 21, whereinthe at least one exit comprises an opening at a distal end of the tube.23. An implant system as in claim 22, wherein the at least one exitfurther comprises a plurality of side openings interspersed along thedistal region of the tube.
 24. An implant system as in claim 21, whereinthe at least one exit comprises a plurality of side openingsinterspersed along the distal region of the tube.
 25. An implant systemas in claim 21, wherein the annular flange is located in the anteriorchamber when the implant is positioned in the eye.
 26. An implant systemas in claim 25, wherein 1 mm to 2 mm of a proximal length of the tube islocated in the anterior chamber when the implant is positioned in theeye.
 27. An implant system as in claim 21, wherein the at least one exitfrom the internal lumen is positioned in the suprachoroidal space whenthe tube is positioned in the eye.
 28. An implant system of claim 21,wherein at least a portion of the elongated member comprises a firstshape that is curved.
 29. An implant system of claim 28, wherein thefirst shape matches a curvature of the eye or a curved contour of thedissection tissue plane.
 30. An implant system of claim 29, wherein theocular implant comprises a second shape that is different from the firstshape of the elongated member, wherein at least one of the first shapeand the second shape changes when the elongated member is insertedthrough the internal lumen of the ocular implant.
 31. An implant systemof claim 21, wherein the delivery instrument is configured to positionthe ocular implant at the deployed location without a sheath surroundingat least a portion of the tube.
 32. An implant system of claim 21,wherein the self-sealing corneal incision comprises an opening in thecornea that is no greater than 2.85 mm in size.
 33. An implant system ofclaim 21, wherein the longitudinal axis is straight.